Biologics and Partial Enteral Nutrition Study

NCT04859088 | Recruiting

• 1 other identifier: GN21RH169
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

Crohn's disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining. It causes diarrhoea, severe abdominal pain, poor nutrition and adversely affects the quality of life of sufferers. Two of the best treatments currently used in people with CD are drug injections and/or infusions (biologics), and a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 40% of the patients, and although treatment with the liquid-only diet has a better safety and effectiveness profile, it is difficult for patients to stick to this as their sole source of nutrition for 6-8 weeks, particularly for adults. BIOPIC study aims to investigate whether replacing half of a habitual diet with specialised milkshakes will improve response to standard treatment with biologics in adults with CD.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Disease; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index

  Comparison of Crohn's Disease Activity Index (CDAI) score (approximate range: 0-600) between the intervention (PEN) and control group (unrestricted diet). Higher CDAI scores indicate worse outcomes. Clinical response is defined as baseline CDAI score decrease of ≥ 70, and clinical remission is defined as CDAI score \<150.

  Baseline to 52 weeks

Secondary Outcomes (18)

• Harvey-Bradshaw Index

  Baseline to 52 weeks

• Faecal Calprotectin

  Baseline to 12 weeks

• Blood C-Reactive Protein

  Baseline to 12 weeks

• Blood Erythrocyte Sedimentation Rate

  Baseline to 12 weeks

• Blood Albumin

  Baseline to 12 weeks

Other Outcomes (4)

• Gut microbiome composition

  Baseline to 12 weeks

• Gut microbiome function

  Baseline to 12 weeks

• 3-day estimated food diary with food photography

  Baseline to 6 weeks

Study Arms (2)

Partial Enteral Nutrition

EXPERIMENTAL

Patients allocated to Partial Enteral Nutrition study arm will be asked to replace 50% of their daily energy requirements with a proprietary formula (Modulen IBD, Nestle) for 6 weeks alongside standard care of treatment with adalimumab as induction therapy.

Dietary Supplement: Partial Enteral Nutrition

Unrestricted diet

NO INTERVENTION

Patients allocated to unrestricted diet study arm will be asked to follow their normal diet for 6 weeks alongside standard care of treatment with adalimumab as induction therapy.

Interventions

Partial Enteral Nutrition DIETARY_SUPPLEMENT

Dietary intervention (Liquid food replacement intervention)

Partial Enteral Nutrition

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (4)

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, Scotland, United Kingdom

RECRUITING

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

RECRUITING

The New Victoria Hospital

Glasgow, G42 9LF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Aleksandra Jatkowska, BSc (Hons)

CONTACT

07743585420; a.jatkowska.1@research.gla.ac.uk

Bernadette E White, MBio (Hons)

CONTACT

07719607863; b.white.1@research.gla.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 26, 2021
• Study Start: September 20, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (4)