One Year Home Monitoring and Treatment of IBS Patients

NCT03586622 | Unknown DMC

• 1 other identifier: H16023499
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Home monitoring; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Symptom Severity (5-Item visual analogue scale, IBS-SSS)

  The IBS-SSS scale is constructed as a five item visual analog scale (VAS) which will be self-administrated by the patients on the web program. And results will be illustrated as a function of time in a traffic light manner to the patients (Mild, Green Zone \<175, Moderate, Yellow Zone 175-300 and Severe, Red Zone \> 300 on the IBS-SSS). IBS-SSS evaluates the intensity of IBS symptoms during the past 10 days with regards to: abdominal pain, distension, bowel habits, and interference with life in general. Each of the five items generates a maximum score of 100, which gives a maximum total score of 500 for all five items. A greater score indicates more severe symptoms. A cut off value for improvement/ responder of 50 point was recommended by Francis et al. 1997 and will also be used in this study to evaluate respond rates in the 2 arms.

  4 weeks

Secondary Outcomes (11)

• Symptom Severity (IBS-SSS) area under the curve (AUC)

  11 months

• Disease course, Copenhagen IBS Disease course Type

  one year

• Compliance, FODMAP adherence Report scale (FARS)

  4 weeks

• Compliance, Medication Adherence Report Scale (MARS)

  4 weeks

• Stool consistency, Bristol Stool Chart

  4 weeks

Study Arms (2)

Low FODMAP diet

EXPERIMENTAL

Low FODMAP diet (LFD) Each IBS patient randomized to the Australian exclusion diet, Low FODMAP diet (LFD) group (n=52) will when allocated to LFD group have a one-hour counseling to the LFD by a nutritionist at the hospital. Within this one hour a diet anamnesis of the patient will be made in order to register the High FODMAP foods the patient is consuming (important that one find good low FODMAP substitutions). Based on the diet anamnesis optimization of the low FODMAP diet counseling can be made. They will receive hands-out with recipes, tips, meal plans, list of suitable low FODMAP foods and folder of foods they should avoid- most of information in the LFD folder patients will also find in the app 'Low FODMAP diet' which they will receive free of charge.

Dietary Supplement: Low FODMAP diet (LFD)

VSL#3®

EXPERIMENTAL

Each IBS patient randomized to the probiotic VSL#3 arm (n=52) will at randomization be given VSL#3 for 4 weeks (56 sachets) together with a leaflet on VSL#3 - holding information on the product from the manufacture regarding storage, nutritional information etc. If the patients have any questions regarding the treatment, they can ask the project investigator handing out the VSL#3 to them. They will be instructed in taking their VSL#3 (2 sachets a day) as described by the manufacturer

Dietary Supplement: VSL#3®

Interventions

Low FODMAP diet (LFD) DIETARY_SUPPLEMENT

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.

Low FODMAP diet

VSL#3® DIETARY_SUPPLEMENT

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.

VSL#3®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fulfilling the Rome III criteria for IBS.
• IBS patients classified as diarrhea or mixed type by the Bristol stool chart.
• Within normal BMI range (18.5-25)
• IBS patients who can read, speak and understand Danish
• Have a smart phone
• IBS patients that can manage going on Internet and wireless networks
• Above 18 years of age
• IBS-SSS\>175

You may not qualify if:

• IBS Patients with diagnosed co-morbidities like diabetes
• IBS patients that have undergone gastrointestinal surgery
• IBS patients on IBS medication
• IBS patients on alternative diets
• IBS patients diagnosed with celiac disease and lactose intolerance
• IBS patients with severe mental disturbance or alcohol/ other drug abuse.
• IBS diagnosed with predominate constipation or unspecified
• Has previously been on low FODMAP diet (Guided by professional nutritionist )
• IBS patients with a BMI below 18.5 and above 25
• IBS patients with a language barrier
• Below 18 years of age

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Colitis-Crohn Foreningen: collaborator
• Ferring Pharmaceuticals: collaborator
• Calpro AS: collaborator
• Muusmann forlag: collaborator
• Statens Serum Institut: collaborator
• Genetic Analysis AS: collaborator

Study Sites (1)

North Zealand university hospital, Gastro unit

Frederikssund, Capital Region, 3600, Denmark

Location

Related Publications (1)

• Ankersen DV, Weimers P, Bennedsen M, Haaber AB, Fjordside EL, Beber ME, Lieven C, Saboori S, Vad N, Rannem T, Marker D, Paridaens K, Frahm S, Jensen L, Rosager Hansen M, Burisch J, Munkholm P. Long-Term Effects of a Web-Based Low-FODMAP Diet Versus Probiotic Treatment for Irritable Bowel Syndrome, Including Shotgun Analyses of Microbiota: Randomized, Double-Crossover Clinical Trial. J Med Internet Res. 2021 Dec 14;23(12):e30291. doi: 10.2196/30291.

  PMID: 34904950 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Pia Munkholm, Professor

  North Zealands University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD and Professor in eHealth and epidemiology

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: September 23, 2018
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)