Probiotics and Irritable Bowel Syndrome

NCT04572932 | Completed DMC

• 1 other identifier: Irritable Bowel Syndrome
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial was conducted on 90 IBS patients, who fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation) in Egyptair hospital outpatient clinic, Cairo, Egypt between May and December 2019. Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.

Conditions

Irritable Bowel Syndrome

Keywords

intestinal microbiota,; probiotics,; quality of life,

Outcome Measures

Primary Outcomes (1)

• Change of IBS Symptoms

  via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)

  4 weeks

Study Arms (2)

group 1:Probiotic arm

ACTIVE COMPARATOR

first group was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily for 4 weeks

Drug: lactobacillus delbruekii

Group 2:Placcebo arm

ACTIVE COMPARATOR

the second group received only itopridehcl 50mg by the same dose for four weeks.

Drug: lactobacillus delbruekii

Interventions

lactobacillus delbruekii DRUG

Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl

Also known as: and lactobacillus fermentum), and itopride hcl

Group 2:Placcebo arm; group 1:Probiotic arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e \[Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)\].

You may not qualify if:

• Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding),
• Known inflammatory bowel disease or celiac disease patients,
• patients above 50 years of age
• immuno-compromised patients
• Refusal to participate in the study

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Tropical medicine department

Cairo, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Tropical Medicine

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 1, 2020
• Study Start: May 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 29, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

EG (1)