Digitally Delivered Dietary Treament for Adult Patients With Irritable Bowel Syndrome: A Pilot Study

NCT07607132 | Completed

• 1 other identifier: 2024-01068-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Two carbohydrate reduced diets, the low FODMAP diet (LFD) and low-carbohydrate diet (LCD), have in randomized controlled studies shown efficacy in relieving symptoms in patients with Irritable Bowel Syndrome (IBS), but access to trained dieticians is limited. Digital delivery may offer a convenient, cost-effective and scalable solution. This pilot study aims to evaluate the effectiveness and feasibility of digitally delivered evidence-based dietary treatments in relieving gastrointestinal, psychological and somatic symptoms and improving quality of life in patients with IBS. Adults with IBS will be recruited via social media and clinical referrals and will receive their choice of the two dietary treatments: LFD with traditional IBS dietary advice or LCD. Participants will get access to the digital platform which contains information about the study, IBS pathophysiology, the treatment diet along with recipes and a mobile application for food scanning. Participants will complete digital questionnaires at baseline and week four to evaluate changes in gastrointestinal symptoms (IBS-SSS), somatic and psychological symptoms (PHQ-15, HADS, VSI) and quality of life (IBS-QoL). Feasibility and adherence is assessed with an evaluation questionnaire.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; dietary treatment; digital

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with significant gastrointestinal symtom reduction

  A responder to treatment is defined as having a symptom reduction \> 50 measured by IBS-SSS

  From baseline vs 4 weeks after starting digital dietary treatment.

Study Arms (1)

Digital delivery of low FODMAP diet or low-carbohydrate diet

OTHER

Other: Digital dietary platform

Interventions

Digital dietary platform OTHER

a digital platform with information about the study, IBS, the treatment diet along with recipes and a mobile application for food scanning.

Digital delivery of low FODMAP diet or low-carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with IBS (Rome IV) by physician
• Age 18-64
• Ability to read and understand Swedish
• Signed informed consent

You may not qualify if:

• Received dietary treatmen for IBS previously
• Manifestations of other conditions that may explain gastrointestinal symptoms
• Manifestation of other serious medical conditions
• Patients with ongoing eating disorders
• Pregnant/lactating women

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Funding: Kostfonden: collaborator

Study Sites (1)

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Effect of digital dietary treatment with either of the two treatments diets. Participants choose from the two diets.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 2, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

SE (1)