Probiotics and Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT04572932
• Recruitment Status: Completed
• First Posted: October 1, 2020
• Last Update Posted: October 5, 2020
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Iman Fawzy Montasser, Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: lactobacillus delbruekii	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Use of Probiotics In Patients With Irritable Bowel Syndrome
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: February 29, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change of IBS Symptoms [ Time Frame: 4 weeks ]
   via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Tropical medicine department

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

More Information

• Responsible Party: Iman Fawzy Montasser, Associate Professor of Tropical Medicine, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04572932
• Other Study ID Numbers: Irritable Bowel Syndrome
• First Posted: October 1, 2020
• Last Update Posted: October 5, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Iman Fawzy Montasser, Ain Shams University:

intestinal microbiota,; probiotics,; quality of life,

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases