Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

University of Mosul100 enrolled

Overview

Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS

Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea

Interventions

Two probiotic strains (L. plantarum and L. acidophilus)DIETARY_SUPPLEMENT

A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 16-55 2. Both genders 3. Patients diagnosed clinically with IBS based on Rome's criteria 4. IBS-Diarrhea only with pain \& distention 5. Duration of symptoms 6 months Exclusion Criteria: 1. Age \> 55 2. Celiac disease 3. Inflammatory bowel disease (ulcerative colitis \& Crohn's) 4. Thyroid disease 5. Colonic CA 6. Lactose intolerance 7. Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy) 8. Preexisting use of antibiotics in the previous 3 months. 9. Preexisting systemic diseases

Locations (1)

University of Mosul

Mosul, Ninevah, Iraq

Outcomes

Primary Outcomes

The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.

The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).

Time frame: Three months

Data from ClinicalTrials.gov

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