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
are over 18 years old;
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);
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).
have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;
have diseases affecting gastrointestinal function, including a history of bariatric surgery;
have allergies or food hypersensitivity (other than lactose intolerance);
have any major dietary restrictions or food allergies;
Parallel
Osteopathic care
Other interventionParticipants 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.
Sham Osteopathic care
Other interventionFor 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
BehavioralIn 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.
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
The IBS Symptom Severity Score (IBS-SSS) will be utilized to evaluate the severity of IBS symptoms. This scale provides an overall score ranging from 0 to 500, with higher scores indicating greater symptom severity. The questionnaire includes the following components: intensity and frequency of abdominal pain, abdominal distension, dissatisfaction with bowel habits, and the overall impact of IBS on daily life ("life interference"). Scores are categorized as follows: 75-175 indicates mild severity, 175-300 represents moderate severity, and 300 or above reflects severe symptoms. The IBS-SSS considered a valid and reliable scale, with a Cronbach's Alpha = 0.80.
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
The IBS Symptom Severity Score (IBS-SSS) will be utilized to evaluate the severity of IBS symptoms. This scale provides an overall score ranging from 0 to 500, with higher scores indicating greater symptom severity. The questionnaire includes the following components: intensity and frequency of abdominal pain, abdominal distension, dissatisfaction with bowel habits, and the overall impact of IBS on daily life ("life interference"). Scores are categorized as follows: 75-175 indicates mild severity, 175-300 represents moderate severity, and 300 or above reflects severe symptoms. The IBS-SSS considered a valid and reliable scale, with a Cronbach's Alpha = 0.80.
3 day dietary dairy
The diary asks for dietary intake information of two weekdays and one day in the weekend. Collected data with the 3-day food diary will allow us to find out approximate calorie intake, micronutrient intake, macronutrient intake of each participant.
Stool Diary
The patients will record all bowel movements over a 10-day period using a stool diary, based on the Bristol Stool Form (BSF) scale. The diary will document stool frequency (number of stools per day), mean stool consistency on a 7-point scale, and will be used to classify IBS subtypes and evaluate bowel habits. Sub-types of IBS are divided into four categories based on the predominant stool form; IBS with predominant constipation (IBS-C, ≥25% hard stools (BSF 1 or 2) and \<25% loose stools (BSF 6 or 7)), IBS with predominant diarrhea (IBS-D, ≥25% loose stools and \<25% hard stools), IBS with alteration between constipation and diarrhea (IBS-M, ≥25% of reported stools hard and ≥25% loose); and un-subtyped IBS (IBS-U, insufficient abnormality of stool consistency to meet criteria for IBS-C, -D, or -M).
Change in Pain intensity
The "Brief Pain Inventory" allows to rate the worst pain in the last 24 hours, the least pain in the last 24 hours, the average pain and the pain intensity at the moment of filling out the questionnaire. This tool also assesses the interference of pain with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep via an 11-point numeric rating pain scale, ranging from 0 (no pain) to 10 (worst pain)
Click on the lead sponsor to view all of their trials.
