Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-06-30

Brief Summary

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Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care.

The main questions it aims to answer are:

Does osteopathic care reduce IBS symptom severity more than sham osteopathic care?

Does osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care?

Do participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention?

Can pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care?

What adverse effects occur with osteopathic care compared to sham care?

Participants will:

Visit the osteopathy clinic to receive four sessions of real or sham osteopathic care

Complete online assessments before and after the intervention, and at 3- and 6-months post-intervention

Provide stool samples before and after the four osteopathic or sham sessions

Keep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention

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Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS) Fibromyalgia (FM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Osteopathic care + flexi FODMAP diet

Group Type EXPERIMENTAL

Osteopathic care

Intervention Type OTHER

Participants allocated to the osteopathic care group will receive 4 weekly consultations of person-centered osteopathic care. Each consultation will last approximately 45 minutes and consist of a careful medical history, a clinical examination, treatment, and advice (e.g. exercise, dietary, lifestyle).

The osteopathic treatment protocol could be labeled as 'custom tailored': the determination of the treatment was left to the clinical judgment of the osteopath, meaning that no predefined, standardized osteopathic protocol would be implemented. Standard osteopathic techniques (Glossary of Osteopathic Terminology) can be applied, including diagnostic techniques (e.g. observation, neurological tests, palpation, and motion testing) and therapeutic direct (e.g. high-velocity low-amplitude, muscle energy), indirect techniques (e.g. strain counter strain, balanced ligamentous tension, balanced membranous tension), or combined techniques.

Flexi-FODMAP Diet

Intervention Type BEHAVIORAL

In addition to the real or sham osteopathic care, all participants will follow a 4-week flexi-FODMAP diet delivered online. Participants will receive structured dietary instructions via a customized online platform, based on the NHS Gentle-FODMAP diet guidelines and informed by expert input from dieticians. This modified "FODMAP-gentle" approach involves a targeted, less restrictive elimination of selected high-FODMAP foods.

Sham osteopathic care + flexi FODMAP diet

Group Type SHAM_COMPARATOR

Sham Osteopathic care

Intervention Type OTHER

For this trial, sham intervention will mimic the osteopathic care according to the "touch equality assumption". Therefore, it mimics a clinical examination and treatment. The sham clinical evaluation involves a full evaluation of the position and mobility of the spine.This screening of the patient will be performed using conventional osteopathic manual tests, without any intention to make a diagnosis. Sham treatment will involve light manual contact, with the subject lying supine on the treatment table.

Flexi-FODMAP Diet

Intervention Type BEHAVIORAL

In addition to the real or sham osteopathic care, all participants will follow a 4-week flexi-FODMAP diet delivered online. Participants will receive structured dietary instructions via a customized online platform, based on the NHS Gentle-FODMAP diet guidelines and informed by expert input from dieticians. This modified "FODMAP-gentle" approach involves a targeted, less restrictive elimination of selected high-FODMAP foods.

Interventions

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Osteopathic care

Participants allocated to the osteopathic care group will receive 4 weekly consultations of person-centered osteopathic care. Each consultation will last approximately 45 minutes and consist of a careful medical history, a clinical examination, treatment, and advice (e.g. exercise, dietary, lifestyle).

The osteopathic treatment protocol could be labeled as 'custom tailored': the determination of the treatment was left to the clinical judgment of the osteopath, meaning that no predefined, standardized osteopathic protocol would be implemented. Standard osteopathic techniques (Glossary of Osteopathic Terminology) can be applied, including diagnostic techniques (e.g. observation, neurological tests, palpation, and motion testing) and therapeutic direct (e.g. high-velocity low-amplitude, muscle energy), indirect techniques (e.g. strain counter strain, balanced ligamentous tension, balanced membranous tension), or combined techniques.

Intervention Type OTHER

Sham Osteopathic care

For this trial, sham intervention will mimic the osteopathic care according to the "touch equality assumption". Therefore, it mimics a clinical examination and treatment. The sham clinical evaluation involves a full evaluation of the position and mobility of the spine.This screening of the patient will be performed using conventional osteopathic manual tests, without any intention to make a diagnosis. Sham treatment will involve light manual contact, with the subject lying supine on the treatment table.

Intervention Type OTHER

Flexi-FODMAP Diet

In addition to the real or sham osteopathic care, all participants will follow a 4-week flexi-FODMAP diet delivered online. Participants will receive structured dietary instructions via a customized online platform, based on the NHS Gentle-FODMAP diet guidelines and informed by expert input from dieticians. This modified "FODMAP-gentle" approach involves a targeted, less restrictive elimination of selected high-FODMAP foods.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

This study includes participants who meet the following criteria:

1. are over 18 years old;
2. have a diagnosis of IBS by a medical doctor according to the Rome IV criteria and have an IBS-SSS score of ≥175 (indicating moderate to severe IBS symptoms);
3. have a medical diagnosis of fibromyalgia or meet the 2016 American College of Rheumatology criteria, characterized by chronic (≥3 months) widespread pain(i.e., a Widespread Pain Index(WPI) score of ≥7 with a Symptom Severity Score of ≥5, or a WPI score of 4-6 with a Symptom Severity Score ≥9 on the Widespread Pain Index).

Participants will be allowed to use probiotic products and follow a lactose-reduced diet, as long as they kept their usual intake throughout the study, unless a further reduction in lactose was recommended for those assigned to diet therapy. IBS medications, including antidepressants, will be allowed if used consistently at a stable dose for at least 2-3month prior to inclusion. Additionally, participants will need to be willing to adjust their current dietary habits in order to take part in the study.

Exclusion Criteria

This study excludes participants who meet any of the following criteria:

1. have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;
2. have diseases affecting gastrointestinal function, including a history of bariatric surgery;
3. have allergies or food hypersensitivity (other than lactose intolerance);
4. have any major dietary restrictions or food allergies;
5. are pregnant or planning pregnancy during the trial (within the next seven months);
6. have a BMI ≤18 kg/m²; or 7) have received osteopathic care for IBS and/or are already following the FODMAP dietary intervention.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No