Irritable Bowel Syndrome Clinical Trial
Official title:
Long Term Effect of Web-based Low FODMAP Diet and Probiotic Treatment VSL#3 on IBS Symptoms and Gut Microbiota
The purpose of this study Is to evaluate if a 4 weeks probiotic VSL#3 treatment and a strict
LFD for 4 weeks are equally good in treating IBS symptoms in IBS patients with diarrhoea or
mixed predominance and further evaluate the long term effect. Hopefully this one year
individualized web-based IBS study will generate a fundament (of course with possibility of
future improvements of the web algorithm) that could be used as a treatment in the primary
care/sector to IBS patients.
This one year study will be carried out based on an eHealth platform
ibsnoh.constant-care.dk, where patients after being educated to self-measure on the
web-program and having a 4 week measuring period on the 'web' before randomization. The
patients will fill out different questionnaires regarding symptom severity, adherence, stool
consistency, quality of life, disease course type, food registration and weight. Some of the
questionnaires are illustrated to the patients in a traffic light manner (Green, Yellow and
Red). They will also self-measure Fecal calprotectin on their smart phones and send in fecal
samples for microbiome analysis. In this randomized cross over study - 104 IBS patients will
be randomized to either a diet low in FODMAPs (fermentable, oligo-, di- and monosaccharides
and polyols, LFD) or the probiotic product VSL#3® for 4 weeks. The probiotic group will
receive 2 sachets a day (450 billons live bacteria in one sachet) for 4 weeks. After 4 weeks
intervention (LFD or VSL#3) non responders, defined as a reduction of less than 50 points in
IBS-SSS will after two weeks wash out period be crossed over. IBS patients randomized to LFD
and responds to LFD will after a reintroduction counselling with dieticians at North Zealand
university hospital after 4 weeks on a strict LFD start reintroducing high FODMAP foods
until symptom flare (individual defined as either Yellow or Red, >175 in IBS-SSS). Hereafter
they will go on a strict LFD again until symptom remission (IBS-SSS below 175, Green zone) -
LFD responders will continue with this procedure for 10 months. IBS patients initially
randomized to VSL#3 and are after 4 weeks of intervention characterized as responders will
not be offered a LFD. Instead they will self- measure on the web with no intervention after
the 4 weeks of VSL#3 treatment. When/if they reach a symptom flare ( again individually
defined as either Yellow or Red, >175 point in IBS-SSS) they will be offered another 4 weeks
VSL#3 treatment.
IBS (irritable bowel syndrome) patients will be recruited from the out-patient clinic of
North Zealand University Hospital, capitol region of Copenhagen, Denmark. Project
investigator will give the patients all relevant information and forms needed to obtain a
written informed consent.
104 IBS patients with diarrhoea or mixed type predominance will be included. They will
self-measure on a web-program the first 4 weeks in order to capture intra individual
variation on the web and giving the patients time to learn how to use the 'tool':
ibsnoh.constant-care.dk, in particular the primary end point IBS-SSS will be filled out
several times during the first 4 weeks. The web algorithm for ibsnoh.constant-care.dk is
specially designed for this trial.
After 4 weeks on the 'web' IBS patients will be randomized to either Low FODMAP diet (LFD)
or VSL#3 probiotic treatment (900 billons live bacteria/day) for 4 weeks. Non responders
(IBS-SSS<50) after 4 weeks intervention will have a 2 weeks wash out period and crossed over
to the other intervention. LFD Responders (IBS-SSS ≥50) will be taught by a nutritionist at
North Zealand University Hospital how to re-introduce foods high in FODMAPs and while
re-introducing tightly monitor on the web-program. If LFD responders during the
reintroduction period (10 months) will encounter a symptom flare individually defined as
either Yellow or Red (that is > 175 on IBS-SSS) they will start on a strict LFD until
symptom remission (<175 IBS-SSS) and so forth during the rest of the year. Responders to
VSL#3 (IBS-SSS ≥50) will self-monitor on the 'web' and if the patients experience a symptom
flare (again individually defined as either Yellow or Red - that is > 175 on IBS-SSS), they
will be offered another 4 weeks VSL#3 treatment.
20 healthy controls will consecutively be included in the study and followed for a year on
the web as well - they will not fill out as many questionnaires and is primarily included to
have a background population and variation regarding the microbiome.
Patients will at inclusion receive their personal log in to ibsnoh.constant-care.dk and
Calprosmart.
Patients will register the below listed:
Severity scores system for IBS (IBS-SSS), web
IBS-QoL (Quality of life), web
Copenhagen IBS disease course, web
Bristol Stool Chart, web
FODMAP adherence rating scale (FARS), web
Medication Adherence Rating Scale (MARS), web
Evaluation questionnaire of the web program, paper/web
Evaluation questionnaire on food habits (only the VSL#3 group), web
Fecal calprotectin (FC) on any smart Phone
Microbiome (patients will send in 2 fecal samples every time they send in samples - one for
microbiome analysis (research biobank) and another one for a fecal biobank for future use.
Weight, web
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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