Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Dietary supplement: Two probiotic strains (L. plantarum and L. acidophilus)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radhwan Al-Zidan; Phone Number: +964 07701885833; Email: radhwan.alzidan@uomosul.edu.iq

Study Locations

• Iraq
  • Ninevah
    • Mosul, Ninevah, Iraq, 41001
      • University of Mosul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard treatment of IBS; Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals.
Experimental: Probiotics + Standard treatment of IBS; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Mosul

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 14, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: IBS; Mucus; Probiotic; Abdominal pain; IBS-D; Abdominal distention; Lactobacilli; L. plantarum; L. acidophilus
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: CCMRE-phA-22-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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