Study on efficacy and safety of Colibiogen® oral in patients with Irritable Bowel Syndrome

MULTICENTRIC RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND 3-ARM PIVOTAL STUDY ON EFFICACY AND SAFETY OF COLIBIOGEN® ORAL IN PATIENS WITH PROVEN DIAGNOSIS OF IRRITABLE BOWEL SYNDROME

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001743-78-DE

Enrollment

Unknown

Registered

2011-05-03

Start date

2011-10-26

Completion date

Unknown

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrom MedDRA version: 19.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Colibiogen oral Product Name: Verum 2 Pharmaceutical Form: Oral solution Other descriptive name: cell free solution of lysed Escherichia coli, strain Laves Concentration unit: million orga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women from 18 –80 years (25% participation of men is desired) Irritable bowel syndrome according to Rome III criteria of American Gastroenterological Association (Longstreth et al. 2006) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 57

Exclusion criteria

Exclusion criteria: Other gastroentestinal diseases of organic root cause including inflammable diseases (Morbus Crohn, Colitis ulcerosa, Diverculitis) Parasitic bowel infections Celiac disease Lactose intolerance Anemia Positive diangnosis of microbes in case of diarrhea sypmtomes Stomach or bowel resections and other relevant gastrointestinal surgery Severe systemic diseases (e.g. carcinoma)

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy compared to placebo;Secondary Objective: Superiority of 3 x daily 5ml Colibiogen oral compared to placebo Superiority of 3 x daily 10ml Colibiogen oral compared to 3 x daily 5ml Safety and Tolerability of Colibiogen oral;Primary end point(s): responder rate regarding global improvement of irritable bowel syndrome responder rate regarding abdominal pain;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: Efficacy compared to placebo;Secondary Objective: Superiority of 3 x daily 5ml Colibiogen oral compared to placebo Superiority of 3 x daily 10ml Colibiogen oral compared to 3 x daily 5ml Safety and Tolerability of Colibiogen oral;Primary end point(s): responder rate regarding global improvement of irritable bowel syndrome responder rate regarding abdominal pain;Timepoint(s) of evaluation of this end point: 24 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): responder rate regarding global improvement of irritable bowel syndrome after 8 weeks responder rate regarding abdominal pain after 8 weeks change of global improvement of irritable bowel syndrome after 8 weeks and after 24 weeks compared to baseline change of abdominal pain after 8 weeks and after 24 weeks compared to baseline change of gastrointestinal symptoms after 8 weeks and after 24 weeks compared to baseline therapy satisfaction after 8 weeks and 24 weeks change of quality of life after 8, 24 and 28 weeks compared to screening and baseline number of subjects using rescue medication number of adverse events;Timepoint(s) of evaluation of this end point: 8 weeks, 24 weeks, 28 weeks	—

Measure

Time frame

Secondary end point(s): responder rate regarding global improvement of irritable bowel syndrome after 8 weeks responder rate regarding abdominal pain after 8 weeks change of global improvement of irritable bowel syndrome after 8 weeks and after 24 weeks compared to baseline change of abdominal pain after 8 weeks and after 24 weeks compared to baseline change of gastrointestinal symptoms after 8 weeks and after 24 weeks compared to baseline therapy satisfaction after 8 weeks and 24 weeks change of quality of life after 8, 24 and 28 weeks compared to screening and baseline number of subjects using rescue medication number of adverse events;Timepoint(s) of evaluation of this end point: 8 weeks, 24 weeks, 28 weeks

—

Countries

Germany

Contacts

Public ContactProject manager

CardioSec Clinical Research GmbH

corina.buschner@cardiosec.de004936178919740

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026