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Completed

NCT Number: NCT04270487

The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme

A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univeristy Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

A randomized controlled trial (Phase IV trial) to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic (otilonium bromide) agent for 470 newly diagnosed or newly treated irritable bowel syndrome patients in primary care.

The primary objective of this trial is to study treatment efficacy (IBS-SSS responder rate) with diet versus medication after 8 weeks of therapy.

The secondary endpoint is to study the quality of life and health economic impact over six months after the start of the initial treatment with diet versus medication.

Finally, patient satisfaction during and after the different treatment modalities, HRU and WPAI-IBS score in subgroups according to IBS stool pattern subtype, faecal microbiota and serotonin synthesis genetic polymorphisms will also be investigated

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible patients are those of either gender, above the age of 18, eligible to give informed consent.
  • Newly diagnosed with or newly to be treated for IBS in primary care, as this is the setting where the majority of these patients is managed. The diagnostic gold standard, in line with clinical practice, will be clinician's diagnostic judgment.
  • Supportive information for the diagnosis of IBS will be provided to the GPs at the initial investigators meeting. This includes: a guidance for diagnosis and potentially useful additional tests based on the Rome IV management algorithm, a Rome IV-based diagnostic questionnaire with pictograms and a list of alarm symptoms.
  • Patients who did not receive treatment over the preceding 3 months, and who did not receive long-term treatment (>3 consecutive weeks) with otilonium bromide in the past are eligible for the trial.

Exclusion criteria

  • Patients not capable to understand or be compliant with the study.
  • Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease), a history of major bowel surgery (not including minimal invasive surgery such as appendectomy or cholecystectomy, but including sigmoidectomy, hemicolectomy and small bowel resections)
  • Patients who received treatment with otilonium bromide in the past for more than 3 weeks consecutively or who received otilonium bromide recently for any duration in the last 3 months.
  • Patients who have used FODMAP or NICE diet before.
  • Patients who recently (last 3 weeks) used other medication for IBS, or who changed their diet for IBS or for any other reason over the last 3 months. To be included in the trial patients should stop these treatments following the advice of their GP (see paragraph 8.9).
  • Patients with diabetes, uncontrolled thyroid disease, active malignant disease (not including patients with cancer free diagnosis for more than 5 years), symptomatic uncontrolled endometriosis.
  • Patients with a major psychiatric disease. The use of a single antidepressant on a stable dose for at least 3 months is allowed (see paragraph 8.9).
  • Patients with drug abuse and/or alcohol abuse.
  • Patients on pharmacologically prepared probiotic formulations (i.e. bought in the pharmacy) will be excluded. The use of probiotic drinks or yoghurts available from food stores, such as Activia®, Yakult ®, Actimel ®, is allowed but should be registered as "complementary treatment"(see paragraph 8.9).
  • Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study. Also excluded are women of childbearing potential not using effective contraception or women planning to become pregnant the next 6 months (see paragraph 8.9). Methods of contraception considered highly effective are: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner or sexual abstinence (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf)

Treatment and study plan

IBS Diet

Other

Patients will be randomized to a diet or a mediation treatment

otilonium bromide

Drug

Patients will be randomized to a diet or a mediation treatment

Primary outcomes

  1. Treatment efficacy of symptom severity

    Time frame: 1.5 year

    IBS-SSS: IBS symptom severity score

    The maximum achievable score is 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and >300 respectively.

    Controls scored below 75 and patients scoring in this range can be considered to be in remission.

    Efficacy of treatment will be assess by calculating the proportion of patients in each arm with a drop of 50 points or more on the IBS-SSS. The higher the drop, the more the patient has improved.

Secondary outcomes

  1. Treatment efficacy in quality of life

    Time frame: 1.5 year

    Assessment will be done with the IBS-QoL questionnaires before and during the study.

    This includes IBS generic functional status and well-being, perceived quality of life specific to IBS, and work disability.

    Quality of life and health economic impact over 6 months after the start of the initial treatment with diet versus medication will be studied.

    Questionnaire includes a 5-point Likert response scale: not at all, slightly, moderately, quite a bit, and extremely or a great deal.

    All items were sum-scored to calculate total scores.

Other outcomes

  1. Quality of life in IBS

    Time frame: 1.5 year

    Euro-Qol quesrionnaire. This questionnaire includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Each dimension has 3 levels: no problems, some problems, extreme problems.

    Additionallty, a VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

    All the scores are taken into account.

  2. Work Productivity and Activity Impairment in IBS

    Time frame: 1.5 year

    Work Productivity and Activity Impairment Questionnaire (WPAI) Levels of work productivity will be assess before and after treatment. The change of work productivity levels before and after treatment will be studied.

    WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows:

    Questions:

    • = currently employed
    • = hours missed due to health problems
    • = hours missed other reasons
    • = hours actually worked
    • = degree health affected productivity while working
    • = degree health affected regular activities

    Scores:

    Multiply scores by 100 to express in percentages. Percent work time missed due to health: Q2/(Q2+Q4) Percent impairment while working due to health: Q5/10 Percent overall work impairment due to health: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)] Percent activity impairment due to health: Q6/10

  3. Depression levels in IBS

    Time frame: 1.5 year

    PHQ: patient health questionnaire

    This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of -not at all,‖ -several days,‖ -more than half the days,‖ and -nearly every day,‖ respectively.

    PHQ-9 total score (sum) for the nine items ranges from 0 to 27.

    Scores represent: 0-5 = mild 6-10 = moderate 11-15 = moderately severe 16-20 = severe depression

    Levels of depression will be assess before and after treatment. The change of depression levels before and after treatment will be studied.

  4. Somatic levels in IBS

    Time frame: 1.5

    PHQ: patient health questionnaire

    This is calculated by assigning scores of 0, 1, and 2 to the response categories of -not at all‖, -bothered a little‖, and -bothered a lot‖, for the 13 somatic symptoms and 2 items from the depression module (sleep and tired) are scored 0 (-not at all‖), 1 (-several days‖) or 2 (-more than half the days‖ or -nearly every day‖).

    PHQ-15 scores (sum of scores) of 5, 10, and 15 represent cutpoints for low, medium, and high somatic symptom severity, respectively.

    Levels of somatization will be assess before and after treatment. The change of somatization levels before and after treatment will be studied.

  5. Anxiety levels in IBS

    Time frame: 1.5 years

    GAD-7 - patient health questionnaire This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively. GAD-7 total score for the seven items ranges from 0 to 21. When screening for anxiety disorders, a recommended cutpoint for further evaluation is a score of 10 or greater.

  6. Health resourse utilisation in IBS

    Time frame: 1.5 years

    Health resourse utilisation in IBS with the HRU questionnaire. Both direct and indirect health costs, including self-costs to patients, will be compared at the different time points (2,4,6 months). They will also be compared to the (retrospective) cost assessment at baseline. The total direct costs of the utilization of healthcare resources associated with IBS will be calculated in terms of (additional) primary care visits, secondary care visits, hospitalizations, diagnostic tests and procedures, prescription and non-prescription medication and complementary therapies.

  7. Genetic prediction to treatment in IBS

    Time frame: 1.5 years

    Exploratory outcome GWAS analysis of IBS genetics. Pathophysiological and treatment predictors will be investigated in an exploratory setting

  8. Microbiome prediction to treatment in IBS

    Time frame: 1.5 years

    Exploratory outcome Microbiome analysis of IBS stool samples. Pathophysiological and treatment predictors will be investigated in an exploratory setting

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care

Acronym: DOMINO

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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