NCT01887483

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

May 27, 2013

Last Update Submit

December 21, 2015

Conditions

Irritable Bowel Syndrome

Keywords

IBSbowel functionprobiotic

Outcome Measures

Primary Outcomes (1)

  • change in functional bowel symptoms

    Validated questionnaire

    week 0, 4, 8, 12 and 16

Secondary Outcomes (5)

  • change in adequate relief of bowel symptoms

    weekly from week 4 to week 12

  • change in stool defecation frequency

    week 0, 4, 8, 12 and 16

  • change in stool microbiota

    week 4, 8, 12 and 16

  • change in prevalence of adverse events

    continuous from week 0 to 16

  • change in stool consistency

    week 0, 4, 8, 12 and 16

Study Arms (2)

Vetal Laban active

ACTIVE COMPARATOR

Vetal Laban with L. acidophilus

Dietary Supplement: Vetal Laban active

Placebo

PLACEBO COMPARATOR

Vetal Laban -like product without L. acidophilus

Dietary Supplement: Placebo

Interventions

Vetal Laban activeDIETARY_SUPPLEMENT

Dairy product with probiotic

Also known as: Vetal Laban, Lactobacillus acidophilus
Vetal Laban active
PlaceboDIETARY_SUPPLEMENT

Dairy product without probiotic

Also known as: Vetal Laban-like product without L. acidophilus
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Fahd Medical City

Riyadh, Saudi Arabia

Location

King Khalid University Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Abdullah Aljahdali, MD

    King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi Arabia

    PRINCIPAL INVESTIGATOR

  • Arthur C Ouwehand, PhD

    Danisco Sweeteners Ltd.

    STUDY CHAIR

  • Anna H Lyra, PhD

    Danisco Sweeteners Ltd.

    STUDY DIRECTOR

  • Suzanne Alodaib, MSc

    Almarai Company, Saudi Arabia

    STUDY DIRECTOR

  • Abed Allehibi, Dr

    King Fahd Medical City

    PRINCIPAL INVESTIGATOR

  • Othman Al-Harbi, Dr

    King Khalid University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 27, 2013

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

SA(2)