NCT01837485

Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome

Completed Phase 2/Phase 3 Last updated 18 April 2013

What this trial tests

Phase 2/Phase 3 trial testing Lactol in Irritable Bowel Syndrome in 82 participants. Completed in 1 March 2013.

Timeline

1 August 2011

Primary endpoint
1 January 2013

1 March 2013

Quick facts

Lead sponsor	Islamic Azad University, Najafabad Branch
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	82
Start date	1 August 2011
Primary completion	1 January 2013
Estimated completion	1 March 2013
Sites	1 location across Iran

Drugs / interventions tested

• Lactol — full drug profile →
• Placebo

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Islamic Azad University, Najafabad Branch

Who can join

Adults 18 to 65, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Abdominal pain
  Time frame: Up to 3 months
  Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.
• Constipation
  Time frame: Up to 3 months
  Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.
• Diarrhea
  Time frame: Up to 3 months
  Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.

Sponsor's own description

Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The efficacy of a synbiotic containing Bacillus Coagulans in treatment of irritable bowel syndrome: a randomized placebo-controlled trial.
   Rogha M, Esfahani MZ, Zargarzadeh AH. · · 2014 · cited 48× · PMID 25120896
2. Synbiotics as Treatment for Irritable Bowel Syndrome: A Review.
   Sommermeyer H, Piątek J. · · 2024 · cited 4× · PMID 39065261 · DOI 10.3390/microorganisms12071493