Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

NCT05523427 | Completed

• 1 other identifier: CCMRE-phA-22-11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Keywords

IBS; IBS-D; Abdominal pain; Abdominal distention; Probiotic; Lactobacilli; Mucus; L. plantarum; L. acidophilus

Outcome Measures

Primary Outcomes (1)

• 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).

  Three months

Study Arms (2)

Standard treatment of IBS

NO INTERVENTION

Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals.

Probiotics + Standard treatment of IBS

EXPERIMENTAL

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.

Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)

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.

Probiotics + Standard treatment of IBS

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16-55
• Both genders
• Patients diagnosed clinically with IBS based on Rome's criteria
• IBS-Diarrhea only with pain \& distention
• Duration of symptoms 6 months

You may not qualify if:

• Age \> 55
• Celiac disease
• Inflammatory bowel disease (ulcerative colitis \& Crohn's)
• Thyroid disease
• Colonic CA
• Lactose intolerance
• Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
• Preexisting use of antibiotics in the previous 3 months.
• Preexisting systemic diseases

Sponsors & Collaborators

• University of Mosul: lead

Study Sites (1)

University of Mosul

Mosul, Ninevah, 41001, Iraq

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: July 19, 2022
• Primary Completion: December 21, 2022
• Study Completion: January 6, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)