Probiotics and Irritable Bowel Syndrome

Evaluation of the Use of Probiotics In Patients With Irritable Bowel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: lactobacillus delbruekii

Detailed Description

The study includes 90 patients assigned into2 equal groups the first was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily, while the second group receivedonly itopridehcl 50mg by the same dose for four weeks.All patients fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation). 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.

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 and immuno-compromised patients were excluded from the study.

The included patients aged from 18 to 50 years fulfilling Rome IV criteria for diagnosis of IBS: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).Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire.

All patients were subjected to initial evaluation byfull history taking, questionnaires for (IBS diagnostic questionnaire, IBS-SSSand QOL -IBS survey), clinical examination, investigations (including CBC, ESR, CRP, random sugar, HbA1c, thyroid profile and stool analysis) and radiological assessment bypelvi-abdominal ultrasound to exclude any organic cause..Group one(45 patients) was prescribed probiotic (lactobacillus delbruekii and l. fermentum) 10billion colony forming units and itopride 50mg three times daily for four weeks while group two was prescribed only itopride 50mg three times daily for four weeks.Then reassessment of the questionnaires was done after 4 weeks of treatment for comparison

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Tropical medicine department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1-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)].

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1:Probiotic arm; 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; Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl; Other Names: and lactobacillus fermentum); and itopride hcl
Active Comparator: Group 2:Placcebo arm; the second group received only itopridehcl 50mg by the same dose for four weeks.	Drug: lactobacillus delbruekii; Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl; Other Names: and lactobacillus fermentum); and itopride hcl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IBS Symptoms	via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)	4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: quality of life,; intestinal microbiota,; probiotics,
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: Irritable bowel syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: To publish the results of this research . further studies on larger number of patients and for longer durtion as future plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No