Biologics and Partial Enteral Nutrition Study

Crohn Disease Clinical Trial

— BIOPIC  

Official title:

Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859088
• Other study ID #: GN21RH169
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: September 2026

Study information

• Verified date: November 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: Aleksandra Jatkowska, BSc (Hons)
• Phone: 07743585420
• Email: a.jatkowska.1[@]research.gla.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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 (TNFa 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-TNFa 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)

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• Partial Enteral Nutrition
Dietary intervention (Liquid food replacement intervention)

Locations

Country	Name	City	State
United Kingdom	Gartnavel General Hospital	Glasgow
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland
United Kingdom	Queen Elizabeth University Hospital	Glasgow	Scotland
United Kingdom	The New Victoria Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiome composition	Comparison of gut microbiome composition measured with 16S rRNA sequencing and shotgun metagenomics between subgroups of patients.	Baseline to 12 weeks
Other	Gut microbiome function	Comparison of gut microbiome function measured with various targeted and untargeted bacterial metabolites (e.g. GC/LC-MS) between subgroups of patients.	Baseline to 12 weeks
Other	3-day estimated food diary with food photography	Comparison of prospective dietary intake measured with 3-day estimated food diaries with the assistance of food photography between subgroups of patients.	Baseline to 6 weeks
Other	EPIC-NORFOLK Food Frequency Questionnaire	Comparison of retrospective dietary intake measured with 130-item EPIC-NORFOLK Food Frequency Questionnaire between subgroups of participants.; Higher consumption/avoidance of specific food groups/products might indicate better outcomes.	Baseline
Primary	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	Harvey-Bradshaw Index	Comparison of Harvey-Bradshaw Index (HBI) score (approximate range: 0-50) between the intervention (PEN) and control group (unrestricted diet).; Higher HBI scores indicate worse outcomes. Clinical response is defined as baseline HBI score decrease of = 3, and clinical remission is defined as score <5]	Baseline to 52 weeks
Secondary	Faecal Calprotectin	Comparison of faecal calprotectin levels between the two groups.; Higher scores indicate worse outcomes.	Baseline to 12 weeks
Secondary	Blood C-Reactive Protein	Comparison of blood C-reactive protein levels between the two groups.; Abnormal values indicate worse outcomes.	Baseline to 12 weeks
Secondary	Blood Erythrocyte Sedimentation Rate	Comparison of blood erythrocyte sedimentation rates between the two groups.; Abnormal values indicate worse outcomes.	Baseline to 12 weeks
Secondary	Blood Albumin	Comparison of blood albumin levels between the two groups.; Abnormal values indicate worse outcomes.	Baseline to 12 weeks
Secondary	Blood Haemoglobin	Comparison of blood haemoglobin levels between the two groups.; Abnormal values indicate worse outcomes.	Baseline to 12 weeks
Secondary	Steroid-free remission	Comparison of steroid-free remission rates between the two groups.	Baseline to 52 weeks
Secondary	Dosage of biologics	Comparison of biologics dose prescribed between the two groups.	Baseline to 52 weeks
Secondary	Blood anti-drug antibodies	Comparison of blood anti-drug antibodies between the two groups.	Baseline to 12 weeks
Secondary	Blood adalimumab	Comparison of blood levels of adalimumab (drug) between the two groups.	Baseline to 12 weeks
Secondary	Micronutrient status	Comparison of micronutrient status measured by NHS laboratories as standard care of treatment between the two groups.; Abnormal values indicate worse outcomes.	Baseline to 12 weeks
Secondary	Blood immunophenotype	Comparison of immunophenotype profiles (characterisation of immune cells) measured with flow cytometry immunophenotyping between the two groups.; Higher levels of specific pro-inflammatory cells indicate worse outcomes.	Baseline to 12 weeks
Secondary	Self-Administered Inflammatory Bowel Disease Questionnaire	Comparison of Self-Administered Inflammatory Bowel Disease Questionnaire (SIBDQ) scores (range: 10-70) between the two groups.; Higher SIBDQ scores indicate better outcomes.	Baseline to 12 weeks
Secondary	Body Mass Index	Comparison of Body Mass Index (BMI) (kg/m2) between the two groups.	Baseline to 12 weeks
Secondary	Body weight	Comparison of body weight (kg) between the two groups.	Baseline to 12 weeks
Secondary	Body fat mass	Comparison of body fat mass (percent, %) measured with Bioelectrical Impedance Analysis between the two groups.	Baseline to 12 weeks
Secondary	Body fat-free mass	Comparison of body fat-free mass (percent, %) measured with Bioelectrical Impedance Analysis between the two groups.	Baseline to 12 weeks
Secondary	Handgrip strength	Comparison of handgrip strength measured with handgrip strength dynamometer between the two groups.	Baseline to 12 weeks