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Biologics and Partial Enteral Nutrition Study

NCT ID: NCT04859088

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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80 adult patients with active CD who are due to start biologic injections therapy with adalimumab as part of their standard of care for the first time will be recruited for this study. Patients will be randomly allocated to replace either half of their normal diet with nutritionally complete milkshakes or to follow their usual diet for 6 weeks. The investigators will compare the proportion of patients whose symptoms and disease markers will improve between the two groups at 6 and 12 weeks, and how many of them will remain symptoms-free for up to a year following treatment. The investigators will also explore whether the half-liquid diet will influence patients' nutrition and quality of life. Last, the investigators will investigate if gut bacteria changes and their metabolites associate with patients' eating habits and their responses to treatment with biologics.

The primary aim of the BIOPIC study is to investigate if replacement of 50% of habitual food intake with a proprietary liquid diet for 6 weeks will improve remission rates at 12 weeks in adult patients with active ileocolonic CD treated with first-line biologics (TNFα antagonists, adalimumab) as their standard treatment of care. The secondary aim is to investigate if replacement of 50% of habitual food intake with a proprietary liquid diet for 6 weeks will prolong remission in adult patients with active ileocolonic CD treated with first-line biologics (TNFα antagonists) as their standard treatment of care.

Conditions

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Crohn Disease

Keywords

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Inflammatory Bowel Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Partial Enteral Nutrition

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.

Group Type EXPERIMENTAL

Partial Enteral Nutrition

Intervention Type DIETARY_SUPPLEMENT

Dietary intervention (Liquid food replacement intervention)

Unrestricted diet

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Partial Enteral Nutrition

Dietary intervention (Liquid food replacement intervention)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Queen Elizabeth University Hospital

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Gartnavel General Hospital

Glasgow, , United Kingdom

Site Status RECRUITING

The New Victoria Hospital

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Aleksandra Jatkowska, BSc (Hons)

Role: CONTACT

Phone: 07743585420

Email: [email protected]

Bernadette E White, MBio (Hons)

Role: CONTACT

Phone: 07719607863

Email: [email protected]

Facility Contacts

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Daniel R Gaya, MBChB (Hons), FRCP, MSc, MD

Role: primary

John P Seenan, MBChB (Hons), FRCP, MRCP

Role: primary

Jonathan C MacDonald, BM (Hons), BSc (Hons), FRCP

Role: primary

Jonathan C MacDonald, BM (Hons), BSc (Hons), FRCP

Role: primary

Other Identifiers

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GN21RH169

Identifier Type: -

Identifier Source: org_study_id