Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523427
• Other study ID #: CCMRE-phA-22-11
• Status: Completed
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: January 2023
• Source: University of Mosul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 6, 2023
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Iraq	University of Mosul	Mosul	Ninevah

Sponsors (1)

Lead Sponsor	Collaborator
University of Mosul

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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