Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)

• Registration Number: NCT05523427
• Lead Sponsor: University of Mosul

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2022-07-19
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Primary Completion: 2022-12-21
• Status Verified: 2023-01
• Study Completion: 2023-01-06
• Last Update Submitted: 2023-01-14
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics + Standard treatment of IBS	Two probiotic strains (L. plantarum and L. acidophilus)	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.

Primary Outcome Measures

Name	Time	Method
The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.	Three months	The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).

Trial Locations

Locations (1)

University of Mosul; 🇮🇶 Mosul, Ninevah, Iraq