Study to Determine Efficacy of Probiotics in Irritable Bowel Syndrome

Phase

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT02545413

IRC/2015/protocol/24

Ages 19-65
All Genders

Study Summary

Irritable bowel syndrome (IBS) is the most common functional GI disorder in which abdominal pain and/or discomfort is associated with changes in bowel habit, and with features of disordered defecation. IBS affects 10-20% of the population and causes a marked reduction of quality of life in affected individuals.The high prevalence of IBS is accompanied by large societal economic burdens and negative effects on the quality of life in affected patients. It is divided into 3 types IBS-D diarrhea predominant, IBS-C constipation predominant, IBS-M mixed sub type.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Positive diagnoses of IBS subtype IBS-D defined by Rome III criteria, and who meet thefollowing criteria: a) Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) b)abdominal pain score of > 3.0 on a 0 to 10 point scale & c) Stool Consistency of atleast one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on atleast 2 days per week
Signed informed consent

Exclusion

Exclusion Criteria:

Patients currently using non-steroidal anti-inflammatory drugs, corticosteroids andmast cell stabilizers, or topical or systemic antibiotics in the past 1 month.
Patients with major abdominal surgery, a history of inflammatory bowel disease ordiverticular disease, celiac disease (by detection of anti-transglutaminase andanti-endomysial antibodies), allergic diseases, including asthma (excluded by familyand personal history and specific anti-IgE antibodies), and other organic orpsychiatric disorders as assessed by medical history, appropriate consultations andlaboratory tests.
Females who are Pregnant, breast-feeding, or not using reliable methods ofcontraception

Study Design

May 01, 2016

December 31, 2017

Study Description

Irritable bowel syndrome (IBS) is the most common functional GI disorder affecting 10-20% of the population and causing a marked reduction of quality of life in affected individuals. An altered brain-gut axis has been accepted as a main pathogenetic mechanism of IBS, which is associated with a dysfunction of the GI autonomic nervous system. These alterations may lead to abnormal visceral hypersensitivity and aberrations of gut motility. Recently, additional potential mechanisms of IBS have emerged including alteration of gut microbiota and low-grade inflammation/immune activation. These factors might lead to abnormal motility and visceral hypersensitivity and contribute to the symptoms. Naïve gut microbiota plays important roles in the maintenance of gut homeostasis by direct bactericidal effects and the evolution of both innate and adaptive immune systems. Gut microbiota is thought to play important roles in the pathogenesis of IBS. This is evident from the fact that IBS occurs more frequently after intestinal infection or antibiotics treatment. Studies have shown that the alterations of the intestinal microbiota are observed in IBS patients.Considering the relationship between alteration of gut microbiota and inflammation of gut, manipulation of gut microbiota by probiotics appears to be an ideal treatment modality for IBS. However, the beneficial effects and efficacy of altering gut microbiota by probiotics to improve the symptoms of IBS have not been consistent in clinical trials and therefore it remains uncertain as an effective treatment.

Connect with a study center

Department of Gastroeneterology, Government Medical College
Kozhikode, Kerala 673008
India
Site Not Available

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