NCT01088971 is a Phase 3 clinical trial of Duolac7S in Irritable Bowel Syndrome, sponsored by Cell Biotech Co., Ltd..

Who is sponsoring NCT01088971?

NCT01088971 is sponsored by Cell Biotech Co., Ltd..

What drugs are being tested in NCT01088971?

Interventions in NCT01088971: Duolac7S, starch.

What condition does NCT01088971 study?

NCT01088971 studies Irritable Bowel Syndrome.

Is NCT01088971 still recruiting?

NCT01088971 is currently completed. Last updated 22 December 2011.

Last reviewed 2011-12-22 · How we verify

NCT01088971

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome

Completed Phase 3 Last updated 22 December 2011

What this trial tests

Phase 3 trial testing Duolac7S in Irritable Bowel Syndrome in 60 participants. Completed in 1 July 2011.

Timeline

1 October 2009

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Cell Biotech Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 October 2009
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across South Korea

Drugs / interventions tested

Duolac7S
starch (STARCH) — full drug profile →

Conditions studied

Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Cell Biotech Co., Ltd.

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.

The improvement of IBS symptoms
Time frame: 6 weeks (symptom diary and weekly questionnaire)
IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7).

Sponsor's own description

Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Irritable Bowel Syndrome

Currently open trials in the same condition.

NCT07235228 — Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients · NA · recruiting
NCT07421011 — Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 · Phase 1 · recruiting
NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
NCT06788444 — Efficacy of Esketamine for Patients With Irritable Bowel Syndrome · NA · recruiting
NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01088971 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cell Biotech Co., Ltd.
Last refreshed: 22 December 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01088971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing