Vetal Laban Intervention Trial Assessing Bowel Symptoms

Irritable Bowel Syndrome Clinical Trial

— KF_2013  

Official title:

A Double-Blind Placebo-Controlled Randomized Clinical Trial Assessing the Effect of 2 Month Consumption of Vetal Laban Including L. Acidophilus on Functional Gastrointestinal Symptoms Among Subjects Fulfilling Rome III Criteria for IBS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01887483
• Other study ID #: KF_2013
• Status: Terminated
• Phase: Phase 4
• First received: May 27, 2013
• Last updated: December 21, 2015
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Saudi Food & Drug Authority
• Study type: Interventional

Clinical Trial Summary

A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females aged 18 to 65 years

• Subjects fulfilling Rome III criteria for IBS

• Sufficient health and orientation for participating in the trial

• Obtained his/her informed consent after verbal and written information.

• Have a high probability for compliance with and completion of the study.

• Body Mass Index (BMI) between 19 and 35.

Exclusion Criteria:

• Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, Crohn's disease, celiac disease, major bowel surgery, recurrent diverticulitis) or severely impaired general health including cancer and cancer therapy.

• Lactose intolerance

• Unwillingness to refrain from probiotic use during the trial

• Use of antibiotics within the 3 preceding months prior to recruitment

• Pregnant, planning pregnancy or lactating

• Expected major lifestyle changes related to nutrition, exercise, travelling etc.

• Participation in a clinical trial with an investigational product or drug within 3 months prior to screening.

• Substance abuse

• Subjects unable to read and understand the questionnaires

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Vetal Laban active
Dairy product with probiotic
• Placebo
Dairy product without probiotic

Locations

Country	Name	City	State
Saudi Arabia	King Fahd Medical City	Riyadh
Saudi Arabia	King Khalid University Hospital	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Danisco	Almarai, Clinart International

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in functional bowel symptoms	Validated questionnaire	week 0, 4, 8, 12 and 16	No
Secondary	change in adequate relief of bowel symptoms	Weekly question	weekly from week 4 to week 12	No
Secondary	change in stool defecation frequency	Validated scale	week 0, 4, 8, 12 and 16	No
Secondary	change in stool microbiota	molecular analyses	week 4, 8, 12 and 16	No
Secondary	change in prevalence of adverse events	Recording of adverse and serious adverse events	continuous from week 0 to 16	Yes
Secondary	change in stool consistency	Validated scale	week 0, 4, 8, 12 and 16	No