One Year Home Monitoring and Treatment of IBS Patients

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Low FODMAP diet (LFD)

The Low FODMAP diet (LFD) is an acronym for Fermentable Oligo-, Di-, and Monosaccharides And Polyols - all of which are small osmotic active carbohydrates or sugar alcohols that are poorly absorbed in the small intestine and therefore easily fermented by the gut microbiota. The fact that they are fermented rapidly and osmotic active makes them potential and likely candidates for causing luminal distension due to accumulation of gas and water in the intestine.

DIETARY_SUPPLEMENT

VSL#3®

VSL#3® is a dietary supplement that helps maintain the balance of the intestinal flora. VSL#3® has been recognized and classified as GRAS (Generally Regarded as Safe) by a panel of experts in the USA for both adult and pediatric IBD and IBS patients. VSL#3® is a probiotic food containing 450 billion freeze-dried live lactic acid bacteria and bifidobacteria from 8 different strains per bag/sachet: Streptococcus thermophilus BT01, Bifidobacteria (B. breve BB02, B. longum\* BL03, B. infantis\* BI04), Lactobacillus acidophilus BA05, Lactobacillus plantarum BP06, Lactobacillus paracasei BP07, Lactobacillus delbrueckii subsp. bulgaricus\*\* BD08; \*Recently reclassified as B. animalis subsp. lactis \*\* Recently reclassified as L. helveticus. The recommended daily dose is 1-2 bags.

Sponsors & Collaborators

• Colitis-Crohn Foreningen

  collaborator OTHER

• Ferring Pharmaceuticals

  collaborator INDUSTRY

• Calpro AS

  collaborator OTHER

• Muusmann forlag

  collaborator UNKNOWN

• Statens Serum Institut

  collaborator OTHER

• Genetic Analysis AS

  collaborator UNKNOWN

• Nordsjaellands Hospital

  lead OTHER

Principal Investigators

• Pia Munkholm, Professor · North Zealands University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-23

Primary Completion

2020-12-20

Completion

2020-12-20

Countries

• Denmark

Study Locations