Irritable Bowel SyndromePhase 4KF_2013NCT01887483
Vetal Laban Intervention Trial Assessing Bowel Symptoms
A Phase 4 study testing Vetal Laban active in people with Irritable Bowel Syndrome, run by Danisco at 2 sites in Saudi Arabia.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Vetal Laban active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
King Fahd Medical City
Riyadh
King Khalid University Hospital
Riyadh
About this study
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
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).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Vetal Laban active, Placebo
- Keywords
- IBS, bowel function, probiotic
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vetal Laban activeDietary supplement
Also called Vetal Laban, Lactobacillus acidophilus
Dairy product with probiotic
PlaceboDietary supplement
Also called Vetal Laban-like product without L. acidophilus
Dairy product without probiotic
| Study group | Role | What they receive |
|---|---|---|
| Vetal Laban active | Active comparator | Vetal Laban with L. acidophilus Receives: Dietary Supplement: Vetal Laban active |
| Placebo | Placebo comparator | Vetal Laban -like product without L. acidophilus Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in functional bowel symptoms
Validated questionnaire
Measured: week 0, 4, 8, 12 and 16
Secondary outcomes (5)
change in adequate relief of bowel symptoms
Weekly question
Measured: weekly from week 4 to week 12
change in stool defecation frequency
Validated scale
Measured: week 0, 4, 8, 12 and 16
change in stool microbiota
molecular analyses
Measured: week 4, 8, 12 and 16
change in prevalence of adverse events
Recording of adverse and serious adverse events
Measured: continuous from week 0 to 16
change in stool consistency
Validated scale
Measured: week 0, 4, 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Slow recruitment, high drop-out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almarai, Clinart International
- Responsible party
- Sponsor
- Investigators
- Abdullah Aljahdali, MD, Principal investigator, King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi ArabiaArthur C Ouwehand, PhD, Study chair, Danisco Sweeteners Ltd.Anna H Lyra, PhD, Study director, Danisco Sweeteners Ltd.Suzanne Alodaib, MSc, Study director, Almarai Company, Saudi ArabiaAbed Allehibi, Dr, Principal investigator, King Fahd Medical CityOthman Al-Harbi, Dr, Principal investigator, King Khalid University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887483
- Sponsor's protocol ID
- KF_2013
- Acronym
- KF_2013
- Status last verified
- Dec 2015
- First submitted
- 27 May 2013
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01887483
- Acronym / sponsor ID
- KF_2013 / KF_2013
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, bowel function, probiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, high drop-out
- Enrolment
- 62 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- Almarai, Clinart International
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vetal Laban active | Active comparator | Dietary Supplement: Vetal Laban activeVetal Laban with L. acidophilus |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboVetal Laban -like product without L. acidophilus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vetal Laban activeAlso: Vetal Laban, Lactobacillus acidophilusDairy product with probiotic | Dietary supplement | Vetal Laban active |
| PlaceboAlso: Vetal Laban-like product without L. acidophilusDairy product without probiotic | Dietary supplement | Placebo |
Primary outcome
change in functional bowel symptoms
Time frame: week 0, 4, 8, 12 and 16
Validated questionnaire
5 secondary outcomes
change in adequate relief of bowel symptoms
Time frame: weekly from week 4 to week 12
change in stool defecation frequency
Time frame: week 0, 4, 8, 12 and 16
change in stool microbiota
Time frame: week 4, 8, 12 and 16
change in prevalence of adverse events
Time frame: continuous from week 0 to 16
change in stool consistency
Time frame: week 0, 4, 8, 12 and 16
Results and safety
The study was stopped early (reason given: Slow recruitment, high drop-out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah Aljahdali, MD principal investigator
King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi Arabia
Arthur C Ouwehand, PhD study chair
Danisco Sweeteners Ltd.
Anna H Lyra, PhD study director
Danisco Sweeteners Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vetal Laban active in people with Irritable Bowel Syndrome, run by Danisco at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment, high drop-out). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in functional bowel symptoms (time frame: week 0, 4, 8, 12 and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.