Probiotics as Adjuvant Therapy in the M… | Clinical Trial

Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome With Diarrhea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mosul

Mosul, Ninevah, 41001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 16-55
Both genders
Patients diagnosed clinically with IBS based on Rome's criteria
IBS-Diarrhea only with pain & distention
Duration of symptoms 6 months

Exclusion criteria

Age > 55
Celiac disease
Inflammatory bowel disease (ulcerative colitis & Crohn's)
Thyroid disease
Colonic CA
Lactose intolerance
Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
Preexisting use of antibiotics in the previous 3 months.
Preexisting systemic diseases

Treatment and study plan

Two probiotic strains (L. plantarum and L. acidophilus)

Dietary Supplement

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.

Primary outcomes

The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.

Time frame: Three months

The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).

Sponsors and collaborators

Lead sponsor

University of Mosul

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Aug 31, 2022
Registry last updated: Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed