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Clinical Trial Summary

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.


Clinical Trial Description

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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02989506
Study type Interventional
Source Nordsjaellands Hospital
Contact Dorit Ankersen, Msc
Phone +4548295905
Email dorit.vedel.ankersen@regionh.dk
Status Not yet recruiting
Phase N/A
Start date February 2017
Completion date December 2019

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