Investigating the effects of a liquid diet on Crohn's disease treatment
Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease
This study is testing if replacing half of your regular meals with special milkshakes can help adults with active Crohn's disease feel better while they start treatment with a medication called adalimumab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Drugs / interventions | adalimumab, methotrexate |
| Locations | 4 sites (Glasgow, Scotland and 3 other locations) |
| Trial ID | NCT04859088 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether replacing half of a habitual diet with specialized milkshakes can enhance the effectiveness of biologic therapy in adults with active Crohn's disease. A total of 80 adult participants will be randomly assigned to either a half-liquid diet or their usual diet for six weeks while starting treatment with adalimumab. The study will assess symptom improvement and disease markers at 6 and 12 weeks, as well as the long-term effects on remission rates and quality of life. Additionally, it will explore the relationship between dietary changes and gut bacteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 16 and older with active Crohn's disease who are beginning treatment with adalimumab.
Not a fit: Patients with certain complications, such as short bowel syndrome or those currently on high doses of steroids, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with Crohn's disease.
How similar studies have performed: Previous studies have shown promising results with dietary interventions in inflammatory bowel disease, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible participants are all adults (≥16 years old) with active CD (defined as Crohn's Disease Activity Index ≥ 150) who are due to initiate standard adalimumab (TNFα antagonist) induction treatment (160 mg day 0, 80 mg at 2 weeks and then 40 mg every 2 weeks). Exclusion Criteria: * Inability to provide written consent to participate in the study * Pregnant and/or breastfeeding individuals * Presence of stoma * Presence of short bowel syndrome * Previous treatment with an anti-TNFα inhibitor * Use of any other biologic therapy or oral small molecule therapy within the last 12 weeks * Patients currently receiving oral or intravenous steroids at a dosage \>20mg/day prednisolone or \>9mg budesonide * Introduction of or change in dose of immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 8 weeks * Use of oral antibiotics within the past 4 weeks * CD with a major fistulising or symptomatic fibrotic stricturing phenotype * Patients tested positive for blood-borne viruses such as HIV and Hepatitis * Patients with untreated tuberculosis (latent or active) * Current enrolment in other studies of an investigational product or dietary intervention * Food allergies, which do not permit participation in the study (e.g., cow's milk allergy)
Where this trial is running
Glasgow, Scotland and 3 other locations
- Glasgow Royal Infirmary — Glasgow, Scotland, United Kingdom (Recruiting)
- Queen Elizabeth University Hospital — Glasgow, Scotland, United Kingdom (Recruiting)
- Gartnavel General Hospital — Glasgow, United Kingdom (Recruiting)
- The New Victoria Hospital — Glasgow, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Aleksandra Jatkowska, BSc (Hons)
- Email: a.jatkowska.1@research.gla.ac.uk
- Phone: 07743585420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.