Claims:1. A nutritional formulation comprising combination of natural ingredients for the management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health.

2. The nutritional formulation of claim 1 acts as a laxative by increasing colonic contents, has anti-inflammatory and prebiotic effect and provides relief from abdominal pain and discomfort in irritable bowel disease or irritable bowel syndrome patients and acts as a fiber supplement to improve gut health.

3. The nutritional formulation of claim 1 and 2, comprising a combination of Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber, optionally an effervescent agent that is capable of releasing CO2 and pharmaceutically acceptable auxiliary ingredients.
4. The nutritional formulation of preceeding claims, further comprises Chia Seed/ Sabza, Resistant maltodextrin, Guar gum, Xanthan gum and/or Pectin.

5. The nutritional formulation of preceeding claims, comprises Psyllium Husk 0.5 gm to 50 gm, Inulin 20 mg – 1000 mg and curcuminoids 0.5 mg to 1000 mg.
6. The nutritional formulation of preceding claims is dispensed as a powder dosage form.
7. The nutritional formulation of claim 3, wherein the effervescent agent may be selected from sodium bicarbonate, sodium carbonate or sodium hydrogen citrate in combination with organic edible acids, such as citric acid or tartaric acid.
8. The nutritional formulation of claim 3, wherein the pharmaceutically acceptable auxiliary ingredients are sweeteners, anti-caking agents and flavoring agent.
9. The nutritional formulation of claim 8, wherein the sweetener may be selected from sucralose, stevia, acesulfame potassium, sucrose, mannitol, saccharin, lactose and aspartame.
10. The nutritional formulation of preceding claims, is prepared by the following steps
a) All the active ingredients Psyllium husk powder, Chicory extract/ inulin, BioSOLVE curcumin, Curcumin fiber and/or Chia Seed Powder/Sabza Powder, resistant maltodextrin, xanthan gum, guar gum and/or pectin) are mixed together;
b) anti-caking agent is added to step a) and it is sifted through a sieve;
c) sweetener is added to step b) optionally followed by effervescent agent that is capable of releasing CO2; and
d) finally the flavoring agent is added and the powder is mixed.
, Description:FIELD OF THE INVENTION
The present disclosure relates to nutritional compositions for management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health. In particular, the present invention relates to nutritional compositions comprising combination of natural ingredients which have laxative, anti-inflammatory and prebiotic effects and a process for preparation of the formulation.

BACKGROUND OF THE INVENTION
Inflammatory bowel disease (IBD) is a chronic disorder of the gastrointestinal tract. The disease is characterized by inflammation of the small intestine and/or the large intestine (colon). Symptoms of IBD include abdominal pain, persistent diarrhea, and colorectal bleeding. The cause for IBD is still elusive, but the disorder is believed to be the result of an exaggerated immune response to components of the intestine, such as intestinal microbes. Genetic predisposition, intestinal microflora composition, as well as lifestyle and environmental conditions affect the risk of developing IBD.

In human beings, the two main subcategories of IBD are ulcerative colitis and Crohn's disease. Both disorders cause inflammation of the digestive tract, but they differ as to the nature and location of the inflammatory reactions in the guts. Ulcerative colitis (UC) is restricted to the colon mucosa and may involve the entire colon or only parts thereof of, such as the rectum. In contrast, Crohn's disease (CD) may affect any part of the gastrointestinal tract, i.e., from mouth to anus, although it commonly affects the lower part of the small intestine (ileum). Further, in contrast to the inflammation caused by ulcerative colitis, the inflammation caused by Crohn's disease extends deep into the intestinal wall.

The course and prognosis of IBD varies widely. For most patients, it is a chronic condition with symptoms lasting for months to years. IBD is most common in young adults, but can occur at any age. The clinical symptoms of IBD include intermittent rectal bleeding, fever, abdominal pain, and diarrhea, which may range from mild to severe. Additional common signs of IBD are anemia and weight loss. 10 to 15% of all IBD patients will require surgery over ten year period. Protracted IBD is a risk factor for colon cancer, and the risk begins to rise significantly after eight to ten years of IBD.

The first line therapy that is often used for IBD is aminosalicylates, which include sulfasalazine and the brands Asacol, Pentasa, Dipentum, and Colazal. When mild to moderate patients flare up, they are often treated with a short course of steroids. For more severe patients or those with more frequent flares, immunosuppressives such as aathioprine (Imuran), 6-MP, and methotrexate are used. Methotrexate and antibiotics are generally not used in UC and it's believed by many physicians that methotrexate does not work in UC. Need for surgery is more prevalent in UC than in CD. There are unmet needs for IBD patients who fail on all of the currently available therapies. Approximately 20% of patients fail all therapies and need surgery in the short term, 40% of patients will require surgery in the long term.

Irritable bowel syndrome, or IBS, is the most prevalent digestive disease. IBS is one of a heterogeneous family of functional gastrointestinal disorders, which are difficult to treat because no single etiology for these disorders is known and thus treatment is directed at controlling symptoms. A defining characteristic of IBS is abdominal discomfort or pain.

Primary treatment of IBS involves counseling and dietary modification. Drug therapy is considered to be beneficial if directed at individual symptoms. For diarrhea predominant cases, antidiarrheal drugs such as loperamide can be used, which treat diarrhea, but not abdominal pain. Since abdominal pain is one of the defining characteristic of IBS, anti-diarrheal drugs do not adequately treat IBS (Jailwala et al., 2000, Ann Intern Med. 2000;133:136-147; Cremonini et al., 2004, Minerva Med 95:427-441). For constipation predominant cases, ispaghula is often used to increase dietary fiber. Where patients have pain and distension as predominant symptoms, anti-spasmolytics are commonly used. Mebeverine and peppermint oil are often used in such cases. Other agents that have been tried for treating IBS include beta-blockers, naloxone, ondansetron, calcium channel blockers, simethicone, leuprorelin, octreotide and cholecystokinin antagonists with variable results (Martindale, The Extra Pharmacopoeia, 31st Edition (1996) p. 1197).

Present treatment of IBD or IBS includes drugs, nutrition supplements, and surgery. Such treatments may be useful to control the disease by inducing or maintaining remission, or by reducing recurrence. However, there still exists a need in the art for additional therapies which are effective and do not have side effects.

US20080003207A1 relates to the use of Bacillus or Clostridium for treating inflammatory bowel disease, such as ulcerative colitis (UC) and Crohn's disease (CD). The use is based on the finding that such live bacteria are effective in treating inflammatory bowel diseases.

Another prior art WO2002007741A1 relates to pharmaceutical compositions suitable for the treatment of chronic diseases associated with the presence of abnormal or an abnormal distribution of microflora in the gastrointestinal tract of a mammalian host. The compositions comprise viable non-pathogenic or attenuated pathogenic Clostridia.

Yet another prior art EP0588474A1 relates to an easily dispersible powder comprising psyllium particles coated with gum arabic. The said composition has use in the treatment for constipation and as fiber supplement.

Another art US20050152989A1 relates to a method for treating irritable bowel syndrome, comprising administering a therapeutically effective amount of a formulation comprising an osmotic laxative such as polyethylene glycol and a fiber such as psyllium fiber or cellulose to a patient in need of such treatment.

Further, as known to the skilled person, combination of different viable micro-organisms in a single formulation may affect the viability, as well as the shelf-life of the formulation.

Inflammatory diseases are currently treated with steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, both of these widely-prescribed drug classes have significant negative side effects, reducing their use in certain segments of the population. Thus, a less complex product would be desirable; especially from a regulatory perspective. There is a need to develop new compositions with novel modes of action that do not produce considerable side effects. The uses of plant extracts as anti-inflammatory therapeutics are widely reported and can provide safe, efficacious, and cost-effective alternatives to synthetic drugs. Hence, there is a need in the art for a composition for use in prevention or treatment of inflammatory bowel disease and inflammatory bowel syndrome in a mammal, such as human being.

The nutritional composition of the present invention addresses this need. The drawbacks and rationales of the prior arts have lead the inventors of the present invention to develop a composition that is efficacious, economical and effective. The nutritional composition of the instant invention does not have any side effects, and has high safety.

OBJECTS OF THE INVENTION
The main object of the present invention is to provide nutritional compositions for management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health.

Another object of the present invention is to provide nutritional compositions comprising a combination of natural ingredients which have laxative, anti-inflammatory and prebiotic effects for management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health.

Yet another object of the present invention is to provide nutritional compositions comprising Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber.

Another object of the present invention is to provide nutritional compositions comprising Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber and/or Chia Seed/ Sabza, Resistant maltodextrin and/or soluble fiber.

Still another object of the present invention is to provide a process for the preparation of the formulation.

SUMMARY OF THE INVENTION
It is an embodiment of the present invention to provide nutritional compositions which comprises combinations of natural ingredients for management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health.

The nutritional formulation of the present invention is dispensed as a powder dosage form.

The natural ingredients used in the present invention are active dietary fiber sources.

The formulation of the present invention comprises Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber.

The formulation further comprises Chia Seed/ Sabza, Resistant maltodextrin and/or soluble fiber.

The nutritional formulation comprises Psyllium Husk in the range of 0.5 gm to 50 gm, Inulin 20 mg – 1000 mg and curcuminoids 0.5 mg to 1000 mg.

The nutritional formulation comprising the combination of Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber exhibits a substantially greater effect against inflammatory bowel disease or inflammatory bowel syndrome than would have been expected from each active alone.

The nutritional formulation of the present invention in prepared by mixing the active dietary fiber sources, optionally an effervescent agent that is capable of releasing CO2 and pharmaceutically acceptable auxiliary ingredients.

The formulation of the present invention containing the dietary fiber sources has laxative, anti-inflammatory and prebiotic effects and is used for the management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health.

DETAILED DESCRIPTION OF THE INVENTION
In order to make the matter of the invention clear and concise, the following definitions are provided for specific terms used in the following description.

As used herein, “inflammatory bowel disease” or “IBD” or “inflammatory bowel syndrome” or “IBS” refers to any of a variety of diseases characterized by inflammation of all or part of the intestines. Examples of inflammatory bowel disease include, but are not limited to, Crohn's disease and ulcerative colitis. Reference to IBD or IBS throughout the specification is exemplary of gastrointestinal inflammatory conditions, and is not meant to be limiting.

The term “management” includes (i) preventing a pathologic condition (eg prophylaxis), (ii) inhibiting the pathologic condition or arresting its development; and/ or (iii) relieving the pathologic condition.

The term "pharmaceutically acceptable" is employed herein to refer to those compounds, materials, compositions and/ or dosage forms which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/ risk.

Effervescent formulations are known in the prior art for various active ingredients. The effervescent formulations generally include an agent which is capable of releasing CO2.

In an embodiment the present invention provides nutritional compositions which comprises combinations of natural ingredients for management of irritable bowel disease (IBD) or irritable bowel syndrome (IBS) and to improve gut health.

The nutritional formulation of the present invention is dispensed as a powder dosage form.

The natural ingredients used in the formulation of the present invention are active dietary fiber sources.

In another embodiment the formulation of the present invention comprises the following natural ingredients - Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber.

The nutritional formulation comprises Psyllium Husk in the range of 0.5 gm to 50 gm, Inulin 20 mg – 1000 mg and curcuminoids 0.5 mg to 1000 mg.

In yet another embodiment the nutritional formulation of acts as a laxative by increasing colonic contents, has anti-inflammatory (systemic as well as local effect) and prebiotic effect and provides relief from abdominal pain and discomfort in irritable bowel disease or irritable bowel syndrome patients and acts as a fiber supplement to improve gut health.

The Psyllium seed includes a husk portion that is a cleaned, dried seed coat of the Psyllium seed. The husk portion is separated from the seed by winnowing and thrashing. Typically, the husk portion of the Psyllium seed is ground into a powder to make the bulk laxative drug. Psyllium seed husk has use as a fiber supplement and a bulk laxative drug because the psyllium seed husk has a capacity for substantial swelling when ingested. This swelling makes the Psyllium husk a useful bulking agent. Ingestion of Psyllium seed husk has been demonstrated to yield a number of benefits to the consumer, including laxation, appetite suppression and cholesterol reduction.

Chicory (Cichorium intybus L.) is a perennial herb. Chicory roots have been used as a digestive aid, diuretic, laxative and mild sedative. Hepatoprotective agents have been described in the seeds. Chicory is recognized as a good source of dietary fibers such as inulin and fructo-oligosaccharides, which have health-promoting properties. Due to its ß-configuration, chicory extract/inulin is resistant to hydrolysis by human digestive enzymes. As a consequence of its indigestibility, inulin reaches the large intestine essentially complete, where it is selectively fermented by colonic bacteria. Inulin improves bowel function and contributes to normal laxation in different ways: on the one hand it leads to softer stools and facilitated excretion, on the other hand it enhances propulsion of colonic contents via chemical (SCFA) and mechanical stimulation (increased bowel content) of the peristaltic reflex.

Curcuminoids, (a mixture of polyphenolic phytochemicals viz., curcumin, demethoxycurcumin and bisdemethoxycurcumin, hereinafter referred to as curcumin) is obtained from the common curry spice, turmeric (Curcuma longa L). It has been scientifically researched that curcumin has effective therapeutic properties. It acts as an antioxidant, anti-inflammatory, antispasmodic, anticoagulant, anticarcinogenic, and is involved in immunomodulatory activities and heals wounds. In Caughey et. al., (J Virol. 2003, 77(19): 10288-94) it is stated that curcumin is one of the most effective natural molecule for many dreadful ailments and age related diseases ever tested in vitro.

The limiting factor of curcumin despite its immense therapeutic effectiveness is due to its poor absorption in the gastrointestinal tract, which reduces its bioavailability. When taken orally, only traces of curcumin appear in the blood, whereas most of the dose is excreted through the feces. The factors that limit the curcumin absorption are the rapid glucuronidation/sulfation of curcumin's phenolic hydroxyl group, the instability of curcumin in aqueous solution at pH 7 and above and hydrophobicity and insolubility in water at acidic pH, when delivered as a dry powder in existing supplements. Most curcumin is never absorbed and simply passes through the GI tract and is excreted.

BioSOLVE curcumin used in the present invention is a water soluble powder composition of curcuminoids and tetrahydrocurcumin (THC) which enhances the bioaccessibility of tetrahydrocurcumin in systemic circulation. THC is a partially reduced product of curcumin, produced during the metabolism of curcumin in intestine. As a transformed product of curcumin, THC is expected to be involved in the physiological and pharmacological activity of curcumin. THC plays an important role in the antioxidant mechanism of curcumin. The free radical scavenging ability of THC is more effective than curcumin.
The BioSOLVE curcumin used in the present invention is protected by a pending patent application under the Applicant’s name (IN201941016775).

The Curcumin fiber used in the present invention shows local anti-inflammatory function by modulating several signaling pathways that ultimately lead to preventing the disruption of intestinal barrier function induced by external dietary factors or endogenous events. Curcumin facilitates the recovery of damaged colonic mucosa in inflammatory bowel disease by activation of dendritic cells to enhance the suppressive functions of regulatory T- cells. Curcumin also exerts the effects on irritable bowel syndrome through regulating neurotransmitters.

Additionally the formulation of the present invention may contain Chia Seed/ Sabza, Resistant maltodextrin and/or soluble fiber.

Chia seed scientifically known as hispanica, are considered to be one of the superfoods bestowed upon us by nature. The seeds are rich in omega-3 fatty acids, fiber, protein antioxidants and calcium. They also act as natural laxative. When brought into contact with water the powder forms a gel which is easily soluble.

Resistant maltodextrin, a soluble dietary fiber, is manufactured from starch. The resistant maltodextrin is in particular a soluble oligo-glucosaccharide fiber.

Suitable soluble fibers include, but are not limited to, pectin (high ester, low ester); carrageenan; alginate (e.g., alginic acid, sodium alginate, potassium alginate, calcium alginate); guar gum; xanthan gum; gum arabic; inulin; agar; and functional blends of two or more of the foregoing.

In an embodiment the formulation of the present invention comprises - Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber and/or Chia Seed/ Sabza, Resistant maltodextrin and/or soluble fiber, optionally an effervescent agent that is capable of releasing CO2 and pharmaceutically acceptable auxiliary ingredients.

The effervescent agent used in the formulation of present invention is selected from sodium bicarbonate, sodium carbonate or sodium hydrogen citrate in combination with organic edible acids, such as citric acid or tartaric acid.

The pharmaceutically acceptable auxiliary ingredients used in the powder formulation of the present invention may be selected from sweeteners, anti-caking agents and flavoring agent.

Suitable sweeteners include sucralose, stevia, acesulfame potassium, sucrose, mannitol, saccharin, lactose and aspartame.

Suitable anti-caking agent may be selected from silicon di oxide, magnesium stearate, light magnesium carbonate, light magnesium oxide, salts of oleic acid with calcium, potassium and sodium, salts of myristic, palmitic and stearic acids with ammonia, calcium, potassium and sodium, powdered cellulose, microcrystalline cellulose (cellulose gel), mannitol, magnesium silicate synthetic, magnesium hydroxide carbonate, magnesium carbonate, isomalt (hydrogenated isomaltulose), calcium carbonate, sodium hydrogen carbonate, sodium sesquicarbonate, talc, etc.

Suitable flavoring agent may be orange, strawberry, citrus, mango, pineapple, lemon, etc.

The nutritional formulation of the present invention comprises Psyllium husk which acts as a laxative by increasing colonic contents, which stimulates propulsion and provides relief from abdominal pain and discomfort in IBS or IBD patients. The composition of the instant invention also contains curcumin which shows anti-inflammatory activity on the ulcers in GI tract and reduction in abdominal pain and discomfort. The composition comprises natural soluble and insoluble fibers which relieves prolong constipation. Inulin is a type of soluble fiber. It is a "fructan"- meaning that it is made up of chains of fructose molecules that are linked together in a way that cannot be digested by small intestine. Instead, it travels to the lower gut, where it functions as a prebiotic, or food source for the beneficial bacteria that live there. Gut bacteria convert inulin and other prebiotics into short-chain fatty acids, which nourish colon cells and provide various other health benefits.

Surprisingly, the combination of Psyllium Husk, Chicory Extract/ Inulin, BioSOLVE Curcumin along with Curcumin fiber exhibits a substantially greater effect against inflammatory bowel disease or inflammatory bowel syndrome than would have been expected from each active alone.

In a further embodiment, the nutritional formulation of the present invention is prepared by the following process:
1) All the active ingredients (Psyllium husk powder/ Ispaghula, BioSOLVE curcumin, Chicory extract/ inulin, Curcumin fiber and/or Chia Seed /Sabza, Resistant maltodextrin and/or soluble fiber are mixed together;
2) Anti-caking agent is added to step 1) and it is sifted through a sieve;
3) Sweetener is added to step 2) optionally followed by effervescent agent that is capable of releasing CO2;
4) Finally the flavoring agent is added and the powder is mixed.
It has been discovered that administering an osmotic laxative and fiber to a patient effectively treats and alleviates the symptoms associated with irritable bowel syndrome. A therapeutically effective regime includes administering the fiber in an amount and at a frequency and for a period of time sufficient to treat irritable bowel syndrome such that the symptoms are reduced or eliminated.
The following examples illustrate the invention in more detail.

EXAMPLES
Example I:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 42.4
2. Chicory Extract / Inulin 20
3. BioSOLVE Curcumin 10
4. Citric Acid 10
5. Resistant Maltodextrin (DE Value < 10) 7.6
6. Curcumin Fiber 5
7. Sodium Bicarbonate 3
8. Orange Flavor 1.6
9. Stevia 0.4
Total 100

Example II:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 40
2. Sucrose 29
3. Chicory Extract / Inulin 20
4. BioSOLVE Curcumin 5
5. Citric Acid 3
6. Orange Flavor 1.6
7. Curcumin Fiber 1
8. Stevia 0.4
Total 100

Example III:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 37
2. Sucrose 29
3. Chicory Extract / Inulin 20
4. BioSOLVE Curcumin 5
5. Citric Acid 3
6. Guar Gum 3
7. Orange Flavor 1.6
8. Curcumin Fiber 1
9. Acesulfame Potassium 0.4
Total 100

Example IV:

Sr No Product %W/W
1. Psyllium Husk/Isabgul 52
2. Sucrose 29
3. Inulin 5
4. BioSOLVE Curcumin 5
5. Citric Acid 3
6. Guar Gum 3
7. Orange Flavor 1.6
8. Curcumin Fiber 1
9. Acesulfame Potasium 0.4
Total 100

Example V:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 52
2. Sucrose 29
3. Inulin 5
4. BioSOLVE Curcumin 5
5. Malic Acid 3
6. Guar Gum 3
7. Orange Flavor 1.6
8. Curcumin Fiber 1
9. Acesulfame Potasium 0.4
Total 100

Example VI:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 52
2. Sucrose 29
3. Inulin 5
4. BioSOLVE Curcumin 5
5. Malic Acid 3
6. Guar Gum 3
7. Orange Flavor 1.6
8. Curcumin Fiber 1
9. Sucralose 0.4
Total 100

Example VII:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 52
2. Sucrose 29
3. Inulin 5
4. BioSOLVE Curcumin 5
5. Tartaric Acid 3
6. Guar Gum 3
7. Orange Flavor 1.6
8. Curcumin Fiber 1
9. Sucralose 0.4
Total 100

Example VIII:

Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 52
2. Palatinose/Isomaltulose 29
3. Inulin 5
4. BioSOLVE Curcumin 5
5. Tartaric Acid 3
6. Guar Gum 3
7. Orange Flavor 1.6
8. Curcumin Fiber 1
9. Sucralose 0.4
Total 100

Example IX:
Sr No Ingredient %w/w
1. Psyllium Husk/Isabgul 55
2. Sucrose 28.5
3. Inulin 5
4. BioSOLVE Curcumin 5
5. Citric Acid 3
6. Orange Flavor 1.6
7. Curcumin Fiber 1
8. Stevia 0.4
9. Anticaking Agent (Cab-o-Sil M5P) 0.5
Total 100

It will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein. Thus, it should be understood that although the present invention has been specifically disclosed by the preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered to be falling within the scope of the invention.

It is to be understood that the values, substituents, phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.