Irritable Bowel SyndromePhase 4NCT01886781
Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
A Phase 4 study testing Lactobacillus plantarum 299v, Run in period and Wash - out period in people with Irritable Bowel Syndrome, run by University of Stellenbosch at 1 site in South Africa.
Trial summary
In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lactobacillus plantarum 299v, Run in period and Wash - out period
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfillment of the Rome II criteria for IBS,
- availability of at least one colonoscopy within the last three years,
- aged 18 or older at the time of screening,
- provision of written informed consent,
- commitment of availability throughout the 12 week study period.
Who cannot join
- major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy,
- current use of antibiotics,
- history of organic intestinal disease,
- pregnant or breastfeeding mothers,
- chronic infectious disease like HIV or tuberculosis, and
- unable to understand English or Afrikaans.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, 6001
About this study
Official title: Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.
Read the detailed description
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lactobacillus plantarum 299v, Placebo comparator, Run in period, Wash - out period
- Keywords
- only constipation and diarrhea predominant, no mixed or alternating types
- 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.
Lactobacillus plantarum 299vDrug
Also called Lp 299v
two capsules of 5 X 10 ^9 c.f.u each
Placebo comparatorDrug
Micro-crystalline cellulose powder, identical taste, texture and appearance
Run in periodOther
Also called Run in period to baseline
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Wash - out periodOther
Also called Wash - out following treatment phase of eight weeks
Wash - out period following treatment phase of eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum 299v | Experimental | Lactobacillus plantarum 299v capsules Receives: Drug: Lactobacillus plantarum 299v; Other: Run in period; Other: Wash - out period |
| Crytalline cellulose powder | Placebo comparator | Placebo capsule, filled with micro-crystalline cellulose powder Receives: Drug: Placebo comparator; Other: Run in period; Other: Wash - out period |
| Run in period | No intervention | Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced. |
| Wash out period | No intervention | Wash out period of two weeks, no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Change in Abdominal Pain Severity
The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500
Measured: Total trial period 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlè Nutrition Institute Africa, National Research Foundation (NRF) (RSA)
- Responsible party
- Principal investigator, Cheryl Stevenson, University of Stellenbosch
- Investigators
- Cheryl Stevenson, M.Sc, Principal investigator, Univeristy of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886781
- Sponsor's protocol ID
- N10-08-270
- Status last verified
- Sep 2014
- First submitted
- 18 Jun 2013
- Last updated
- 29 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01886781
- Acronym / sponsor ID
- N10-08-270
- Conditions
- Irritable Bowel Syndrome
- Keywords
- only constipation and diarrhea predominant, no mixed or alternating types
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- Nestlè Nutrition Institute Africa, National Research Foundation (NRF) (RSA)
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.
Detailed description
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum 299v | Experimental | Drug: Lactobacillus plantarum 299v, Other: Run in period, Other: Wash - out periodLactobacillus plantarum 299v capsules |
| Crytalline cellulose powder | Placebo comparator | Drug: Placebo comparator, Other: Run in period, Other: Wash - out periodPlacebo capsule, filled with micro-crystalline cellulose powder |
| Run in period | No intervention | –Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced. |
| Wash out period | No intervention | –Wash out period of two weeks, no treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- fulfillment of the Rome II criteria for IBS,
- availability of at least one colonoscopy within the last three years,
- aged 18 or older at the time of screening,
- provision of written informed consent,
- commitment of availability throughout the 12 week study period.
Key exclusion criteria (6 listed)
- major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy,
- current use of antibiotics,
- history of organic intestinal disease,
- pregnant or breastfeeding mothers,
- chronic infectious disease like HIV or tuberculosis, and
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 |
|---|---|---|
| Lactobacillus plantarum 299vAlso: Lp 299vtwo capsules of 5 X 10 ^9 c.f.u each | Drug | Lactobacillus plantarum 299v |
| Placebo comparatorMicro-crystalline cellulose powder, identical taste, texture and appearance | Drug | Crytalline cellulose powder |
| Run in periodAlso: Run in period to baselineRun -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo | Other | Crytalline cellulose powder, Lactobacillus plantarum 299v |
| Wash - out periodAlso: Wash - out following treatment phase of eight weeksWash - out period following treatment phase of eight weeks | Other | Crytalline cellulose powder, Lactobacillus plantarum 299v |
Primary outcome
A Change in Abdominal Pain Severity
Time frame: Total trial period 12 weeks
The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Cheryl Stevenson, M.Sc principal investigator
Univeristy of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus plantarum 299v, Run in period and Wash - out period in people with Irritable Bowel Syndrome, run by University of Stellenbosch at 1 site in South Africa.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Change in Abdominal Pain Severity (time frame: Total trial period 12 weeks). 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 29 Sep 2014.