Irritable Bowel Syndrome With Diarrhea Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome
Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI clinical studies, including for IBS.In the present study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in individuals with IBS-D.
Several strains of Lactobacillus genus have previously been assessed in patients with IBS in multiple randomized controlled trials, demonstrating the efficacy of these strains in reducing IBS-related symptoms such as abdominal pain, distension and flatulence. We hypothesize the L. plantarum UALp-05 strain to benefit research participants by reducing pain severity, normalizing diarrhea predominant stool type and subsequently improving quality of life (QOL) standards. The current study with L. plantarum UALp-05, will include a lower dose of 1 billion CFU/day (considered a low dose among probiotic IBS studies) and a higher dose of 10 billion CFU/ day (considered a mid-point dose among probiotic IBS studies) for a period of 8-weeks.Each probiotic dosage group will be assessed individually in comparison to placebo. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00552565 -
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 3 | |
Completed |
NCT02959983 -
Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use
|
Phase 4 | |
Withdrawn |
NCT02320318 -
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 3 | |
Completed |
NCT01303224 -
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
|
Phase 2 | |
Recruiting |
NCT05646186 -
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
|
N/A | |
Recruiting |
NCT03806959 -
Interest of Pan-capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy
|
N/A | |
Completed |
NCT04129619 -
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 2 | |
Recruiting |
NCT04855799 -
GI Permeability Change in Response to Aquamin®
|
Phase 2 | |
Completed |
NCT04662957 -
Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT04557215 -
Efficacy and Safety of Rifaximin With NAC in IBS-D
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT05311293 -
Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
|
||
Completed |
NCT05277428 -
Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1
|
N/A | |
Not yet recruiting |
NCT03221790 -
Effect of FODMAPs on Mucosal Inflammation in IBS Patients
|
N/A | |
Completed |
NCT03557788 -
Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome
|
Phase 4 | |
Completed |
NCT02757105 -
Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
|
Phase 2 | |
Enrolling by invitation |
NCT06432569 -
Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1)
|
N/A | |
Recruiting |
NCT04830410 -
The Effects of Carbohydrates in Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT03245645 -
FODMAP Reintroduction in Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT02107196 -
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 3 | |
Terminated |
NCT02120027 -
52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 3 |