One Year Home Monitoring and Treatment of IBS Patients

Irritable Bowel Syndrome Clinical Trial

Official title: Home Monitoring of IBS Patients: Long Term Effect of Low FODMAP Diet With Re-introduction and Probiotic Treatment VSL#3 on IBS Symptoms and Gut Microbiota

Status Active, not recruiting

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 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 ibs.constant-care.com. Patients will self-measure on the web-program the first 4 weeks before randomization. The patients will fill out different questionnaires regarding symptom severity, adherence, stool consistency and frequency, quality of life, disease course type, food registration and weight. Nearly all 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 billions 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. Before enrollment, Patients will receive education on IBS and good toilet habit (squatty potty) etc. They will hereafter 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': ibs.constant-care.com, in particular the primary end point IBS-SSS will be filled out several times during the first 4 weeks. The web algorithm for ibs.constant-care.com 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 billions live bacteria/day) for 4 weeks. Patients randomized to the LFD group will be educated by a nutritionist in the diet and taught how to use a Danish Low FODMAP diet app in order to adhere to the LFD.

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 (Two Factor Authentication, 2FA) to ibs.constant-care.com 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 and frequency, web FODMAP adherence rating scale (FARS), web Medication Adherence Rating Scale (MARS), web Evaluation questionnaire of the web program, web Evaluation questionnaire on food habits, web Fecal calprotectin (FC) on any smart Phone (CalproSmart app) 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 IBS-SSS, QoL, BSC and frequency, FARS, MARS, FC, weight/BMI will be illustrated longitudinally to the patients in a traffic light manner (for ease of interpretation). ;

Related Conditions & MeSH terms

• Dietary Modification
• eHealth
• Irritable Bowel Syndrome
• Microbiome
• Probiotics

• NCT number: NCT03586622
• Study type: Interventional
• Source: Nordsjaellands Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2018
• Completion date: December 20, 2020