UMIN-CTR Clinical Trial

Public title

Effectiveness of a Comprehensive eHealth System for Improving QOL in Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial on Brain-Gut-Microbiota Axis

Acronym

Effectiveness of Online Learning and Self-Care Program for Symptom Improvement in Irritable Bowel Syndrome

Scientific Title

Efficacy of a Comprehensive eHealth Self-Management Program for Symptom Reduction and Quality of Life Improvement in Irritable Bowel Syndrome: A Randomized Controlled Trial Investigating the Brain-Gut-Microbiota Axis

Scientific Title:Acronym

COSMOS-IBS Study

Region

Japan

Condition

Irritable Bowel Syndrome

Classification by specialty

Gastroenterology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the effectiveness of a comprehensive eHealth self-management system (including diet, exercise, rest, and neurofeedback methods) for patients with Irritable Bowel Syndrome (IBS). We aim to compare this system with conventional leaflet-based education to determine the extent to which it contributes to IBS symptom improvement and quality of life enhancement. Additionally, we seek to elucidate the underlying mechanisms through the brain-gut-microbiota axis. By assessing the impact of this comprehensive eHealth system on IBS symptom relief, psychological stress reduction, and normalization of intestinal environment from multiple perspectives, this research will contribute to the development of more effective self-care support systems for IBS patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change in Irritable Bowel Syndrome Severity Index (IBS-SI) score
Measurement method: Self-reported IBS-SI questionnaire
Measurement timing: Baseline (pre-intervention), 6 weeks post-intervention, and 3 months post-intervention
Assessment content: Comprehensive IBS symptom severity including abdominal pain intensity, frequency, abdominal bloating, satisfaction with bowel habits, and interference with daily life
Primary evaluation point: Change in IBS-SI score from baseline to 3 months post-intervention

Key secondary outcomes

1. Changes in gut microbiota diversity and composition
Measurement method: Metagenomic analysis of fecal samples
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention

2. Changes in brain wave patterns
Measurement method: Electroencephalogram (EEG) measurements
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention
Assessment content: Resting-state brain activity and brain activity related to interoceptive processing

3. Improvement in IBS-specific quality of life (IBS-QOL) score
Measurement method: IBS-QOL questionnaire
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention

4. Interoceptive awareness
Measurement method: Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention

5. Changes in eating behavior patterns
Measurement method: Eating Behavior Scale (EBS) and FODMAP intake assessment
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention

6. Changes in psychological measures
Measurement method: Visceral Sensitivity Index (VSI) and K6 questionnaire
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention

7. Autonomic nervous system function
Measurement method: Autonomic assessment via finger photoplethysmography
Measurement timing: Baseline, 6 weeks post-intervention, and 3 months post-intervention

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food	Behavior,custom	Other

Interventions/Control_1

Comprehensive eHealth System Group (Enhanced Intervention Group)
Duration and Frequency:

Total intervention period: 3 months (12 weeks)
eLearning (diet, exercise, rest):

1. 5-chapter structure (Chapter 1: Understanding irritable bowel syndrome, Chapter 2: Coping methods, Chapter 3: Additional coping methods, Chapter 4: Medical treatments, Chapter 5: Summary and information)
- Each chapter approximately 45 minutes (8-10 videos of less than 5 minutes each), total learning time approximately 3 hours 45 minutes
- Participants can view contents at their own pace and as many times as desired during the intervention period

2. Neurofeedback training:
- Using InteraXon Muse2 portable EEG device
- Frequency: Twice per week
- Duration per session: Approximately 1 hour (34-minute sessions with 5-minute training periods followed by 1-minute rest periods)
- Total: 24 sessions (12 weeks * 2 sessions per week)

3. Exercise habit: Addition of 1,000-2,000 extra steps per day beyond normal activity level
- Continuous monitoring of steps, rest periods, and sleep rhythms using Fitbit device worn throughout the intervention period

Interventions/Control_2

Leaflet Group (Standard Guidance Group)
Duration and Frequency:
- Total intervention period: 3 months (12 weeks)

Intervention content: One-time explanation of IBS informational leaflet by the principal investigator and research collaborators at the start of the study
- The leaflet contains basic knowledge about irritable bowel syndrome and general coping methods
- Participants keep the leaflet at home and can refer to it freely during the intervention period

Continuous monitoring of steps, rest periods, and sleep rhythms using Fitbit device worn throughout the intervention period (data collection only, without specific guidance)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Female

Key inclusion criteria

1. Gender: Female
2. Age: 20-65 years old
3. Having symptoms of Irritable Bowel Syndrome (IBS) based on Rome IV diagnostic criteria
4. Japanese ethnicity
5. Ability to understand the purpose and procedures of the research and willingness to participate voluntarily
6. Ability to provide written informed consent
7. Having access to the internet and an environment capable of utilizing the e-learning system (or ability to use loaned devices during the research period)
8. Ability to participate in required assessments (baseline, 6 weeks, and 3 months) during the research period (3 months)
9. Ability to provide fecal samples

Key exclusion criteria

1. Diagnosed with psychiatric disorders (depression, anxiety disorders, schizophrenia, eating disorders, etc.)
2. Diagnosed with gastrointestinal diseases other than IBS (inflammatory bowel disease, celiac disease, gastrointestinal malignancies, etc.)
3. Use of antibiotics within the past 3 months
4. Using electronic medical devices such as cardiac pacemakers (due to potential interference with EEG measurement devices)
5. Individuals deemed unsuitable for research participation by the researchers
6. Pregnant or breastfeeding women
7. Individuals with severe constipation or diarrhea requiring medical intervention
8. Currently receiving specific drug treatment for IBS with planned medication changes during the research period
9. Previous experience with structured psychological interventions for IBS (such as cognitive behavioral therapy)
10. Participation in other clinical trials

Target sample size

40

Name of lead principal investigator

1st name	Hamaguchi
Middle name
Last name	Toyohiro

Organization

Saitama Prefectural University

Division name

Department of Rehabilitation, Graduate School of Health Sciences

Zip code

343-8540

Address

820, Sannomiya, Koshigaya City, Saitama Prefecture

TEL

048-973-4125

Email

hamaguchi-toyohiro@spu.ac.jp

Name of contact person

1st name	Kaneko
Middle name
Last name	Mutsumi

Organization

Saitama Prefectural University

Division name

Secretariat, Research and Community Relations

Zip code

343-8540

Address

820, Sannnomiya, Koshigaya City, Saitama Prefecture

TEL

048-973-4120

Homepage URL

Email

shorei@spu.ac.jp

Institute

Saitama Prefectural University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee, Saitama Prefectural University

Address

820, Sannnomiya, Koshigaya City, Saitama Prefecture

Tel

0489734120

Email

shorei@spu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

埼玉県立大学（埼玉県）

Date of disclosure of the study information

2025

Year

05

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

05

Month

20

Day

Date of IRB

Anticipated trial start date

2025

Year

06

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

05

Month

13

Day

Last modified on

2025

Year

05

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066124