The efficacy and safety of Lactobacillus plantarum 299v in patients with IBS will be investigated in a double-blind, randomised, placebo-controlled study. The Sponsor has earlier got an approved health claim in Sweden for gut health and intake of…
ID
Source
Brief title
Condition
- Gastrointestinal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary object is to determine the effect of Lactobacillus plantarum 299v
on abdominal pain over 4 weeks of consumption in comparison to placebo in IBS
out-patients determined with pain nummeric rating scale (NRS). The primary
efficacy endpoint ischange from baseline in abdominal pain NRS after 4 weeks.
Secondary outcome
- The effect of Lactobacillus plantarum 299v on the total scores of IBS
severity scoring system (IBS-SSS) over 4 weeks consumption with placebo in IBS
out-patients
- The effect of Lactobacillus plantarum 299v on flatulence over 4 weeks
consumption in comparison with placebo in IBS out-patients determined with a
flatulence scale
- The effects of Lactobacillus plantarum 299v on bloating over 4 weeks
consumption in comparison with placebo in IBS out-patients determined with
IBS-SSS
- The effects of Lactobacillus plantarum 299v on stool form and frequency
according to the Bristol stool form (BSF) over 4 weeks consumption in
comparison with placebo in IBS out-patients
- The effects of Lactobacillus plantarum 299v on faecal microflora after 4
weeks consumption in comparisons with placebo
- The effects of Lactobacillus plantarum 299v on gastrointestinal (GI)
wellbeing/comfort after 4 weeks consumption in comparison with placebo
-The effects of Lactobacillus plantarum 299v on global efficacy after 4 weeks
consumption in comparison with placebo
- The frequency of Adverse Events collected during the study
Background summary
Irrirable Bowel Syndrome (IBS) is a complex condition with variable
symptomatology involving mucosal integrity and function, gut function, visceral
perception and brain-gut dysregulation. Although IBS is a multi-symptom
disorder abdominal pain or discomfort is its definitive characteristic and is a
predominant feature of the IBS illness experience. Abdominal pain independently
drives health related quality of life decrements in IBS and is the principal
driver of patient reported symptom severity.
Lactobacillus plantarum 299v has in previous studies been shown to decrease
pain and flatulence in patients with IBS. The studies were double blind and
placebo controlled. Patients with IBS were given a diet supplement or a fruit
drink with or without Lactobacillus plantarum 299v and IBS-symptoms were
followed during 4 weeks.
Lactobacillus plantarum is often present in the human gut as well as in many
types of food such as fermented vegetables, yoghurt, cheese and berries.
Study objective
The efficacy and safety of Lactobacillus plantarum 299v in patients with IBS
will be investigated in a double-blind, randomised, placebo-controlled study.
The Sponsor has earlier got an approved health claim in Sweden for gut health
and intake of Lactobacillus plantarum 299v based on three human trials
(Johansson et al. 1998, Nobaek et al. 2000, Niedzielin et al. 2001). However,
since July 1, 2007, health claims made in relation to food products require
authorisation under Regulation EC 1924/2006 before they can be used in the
labelling and marketing of these products in the EU. These three references
were therefore sent in for evaluation of a health claim pursuant article 13.1
of regulation no 1924/2006 but a negative opinion was published (EFSA Journal
2011:9(4):2037). According to the opinion the evaluated studies had some
different shortcomings such as insufficient control for other substances
besides Lactobacillus plantarum 299v and unsatisfactory information about the
validity of the used scales. Since then one further study with positive results
has been done (Ducrotté et al. 2012) but recently one study with
non-significant results was finished in Denmark. To be able to have an approved
health claim in EU it is therefore need to perform at least one more study
showing positive results.
The safety of these lactic acid bacteria has also been proven by many years of
use in food and in clinical trials. Therefore, one may also assume a good
benefit/risk ratio for this nutrional study.
Study design
The study is a randomised, placebo-controlled, double-blind, parallel, single
centre intervention study with IBS out-patients. A total of 200 male and
female patients with IBS are planned to be randomised at 1 site in The
Netherlands. Patients with IBS according to the Rome III criteria can be
considered for participation in this study. The patient will receive
information about the study and after a screening visit and a 2 week run-in
period patients with abdominal pain score between 3-6 on a 0-10 point Linkert
scale with a frequency of at least two days a week will subsequently be
randomised to receive either Lactobacillus plantarum 299v or placebo capsules
for 4 weeks.
A total of 385 patients are planned to be enrolled and 200 patients are planned
to be randomised with 100 patients each arm. The total duration for the patient
in the study will be 6 weeks.
Intervention
Capsules with Lactobacillus plantarum 299v or placebo
Study burden and risks
A benefical effect of Lactobacillus plantarum 299v on gastrointestinal health
has already been found in clinical trials. The safety of these lactic acid
bacteria has also been proven by many years of use in food and in clinical
trials. Therefore, one may also assume a good benefit/risk ratio for this
nutrional study.
By taking part in this study, the patient will receive extra attention for and
insight in his/her health problem. For this the patient will have to visit the
centre for 3 visits, have to complete questionnaires, keep a diary (by
telephone), undergo vital signs measurement , withhold from the use of
probiotic products or drugs (interfering with study evaluation) for 4-6 weeks,
use of antibiotics for 8-10 weeks. Furthermore, samples of the faeces and one
bloodsample will be collected.
Ideon Gamma 1
Lund SE-22370
SE
Ideon Gamma 1
Lund SE-22370
SE
Listed location countries
Age
Inclusion criteria
- Willing and able to provide informed consent
- Age *18 and * 70 years at Visit 1
- IBS according to the Rome III criteria
- A score on abdominal pain NRS * 3 and * 6 at least two days a week measured the weeks before Visit 2 (baseline)
- IBS-SSS * 75 and * 300 at Visit 2 (baseline)
- Ability and willingness to understand and comply with the study procedures
Exclusion criteria
- Known intolerance or allergy to milk products (protein or lactose) or gluten
- History of alcohol or substance abuse six months prior to screening
- Known Hepatitis B or C Human Immunodeficiency Virus (HIV) 1 or 2
- Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
- Abnormal results of the screening laboratory tests clinicallly relevant for study participation, as judged by the Investigator
- Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the Investigator
- Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the Investigator
- Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the Investigator
- Severe psychiatric disease as judged by the Investigator
- Lack of suitability for participation in the study for any reason as judged by the Investigator
- Use of other probiotic products (according Sponsor's list) from Visit 1 and throughout the study
- Consumption of antibiotic drugs 1 month prior to screening and throughout the study
- Consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the Investigator
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46427.060.13 |