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OpenTrials
Completed

NCT Number: NCT07607132

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients with significant gastrointestinal symtom reduction

    Time frame: From baseline vs 4 weeks after starting digital dietary treatment.

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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Funding: Kostfonden

Registry information

Official study title

Digitally Delivered Dietary Treament for Irritable Bowel Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 26, 2026
Registry last updated
May 28, 2026

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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