Crohn DiseaseBIOPICNCT04859088
Biologics and Partial Enteral Nutrition Study
A study testing Partial Enteral Nutrition in people with Crohn Disease, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Partial Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 20 Sep 2021to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
Daniel R Gaya, MBChB (Hons), FRCP, MSc, MD
- Recruiting
Queen Elizabeth University Hospital
Glasgow, Scotland
John P Seenan, MBChB (Hons), FRCP, MRCP
- Recruiting
Gartnavel General Hospital
Glasgow, G12 0YN
Jonathan C MacDonald, BM (Hons), BSc (Hons), FRCP
- Recruiting
The New Victoria Hospital
Glasgow, G42 9LF
Jonathan C MacDonald, BM (Hons), BSc (Hons), FRCP
About this study
Official title: Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease
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.
Read the detailed 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.
- Conditions
- Crohn Disease
- Being tested
- Partial Enteral Nutrition
- Keywords
- Inflammatory Bowel Disease, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Enteral NutritionDietary supplement
Dietary intervention (Liquid food replacement intervention)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 52 weeks
Secondary outcomes (18)
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]
Measured: Baseline to 52 weeks
Faecal Calprotectin
Comparison of faecal calprotectin levels between the two groups.
Higher scores indicate worse outcomes.
Measured: Baseline to 12 weeks
Blood C-Reactive Protein
Comparison of blood C-reactive protein levels between the two groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 12 weeks
Blood Erythrocyte Sedimentation Rate
Comparison of blood erythrocyte sedimentation rates between the two groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 12 weeks
Blood Albumin
Comparison of blood albumin levels between the two groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 12 weeks
Blood Haemoglobin
Comparison of blood haemoglobin levels between the two groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 12 weeks
Steroid-free remission
Comparison of steroid-free remission rates between the two groups.
Measured: Baseline to 52 weeks
Dosage of biologics
Comparison of biologics dose prescribed between the two groups.
Measured: Baseline to 52 weeks
Blood anti-drug antibodies
Comparison of blood anti-drug antibodies between the two groups.
Measured: Baseline to 12 weeks
Blood adalimumab
Comparison of blood levels of adalimumab (drug) between the two groups.
Measured: Baseline to 12 weeks
Micronutrient status
Comparison of micronutrient status measured by NHS laboratories as standard care of treatment between the two groups.
Abnormal values indicate worse outcomes.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
Body Mass Index
Comparison of Body Mass Index (BMI) (kg/m2) between the two groups.
Measured: Baseline to 12 weeks
Body weight
Comparison of body weight (kg) between the two groups.
Measured: Baseline to 12 weeks
Body fat mass
Comparison of body fat mass (percent, %) measured with Bioelectrical Impedance Analysis between the two groups.
Measured: Baseline to 12 weeks
Body fat-free mass
Comparison of body fat-free mass (percent, %) measured with Bioelectrical Impedance Analysis between the two groups.
Measured: Baseline to 12 weeks
Handgrip strength
Comparison of handgrip strength measured with handgrip strength dynamometer between the two groups.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start20 Sep 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859088
- Sponsor's protocol ID
- GN21RH169
- Acronym
- BIOPIC
- Status last verified
- Nov 2021
- First submitted
- 15 Apr 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be asked to provide written consent for their anonymised data to be made available to public repositories.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease
- ClinicalTrials.gov ID
- NCT04859088
- Acronym / sponsor ID
- BIOPIC / GN21RH169
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disease, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Enteral Nutrition | Experimental | Dietary Supplement: Partial Enteral NutritionPatients 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. |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Enteral NutritionDietary intervention (Liquid food replacement intervention) | Dietary supplement | Partial Enteral Nutrition |
Primary outcome
Crohn's Disease Activity Index
Time frame: Baseline to 52 weeks
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.
18 secondary outcomes
Harvey-Bradshaw Index
Time frame: Baseline to 52 weeks
Faecal Calprotectin
Time frame: Baseline to 12 weeks
Blood C-Reactive Protein
Time frame: Baseline to 12 weeks
Blood Erythrocyte Sedimentation Rate
Time frame: Baseline to 12 weeks
Blood Albumin
Time frame: Baseline to 12 weeks
Blood Haemoglobin
Time frame: Baseline to 12 weeks
Steroid-free remission
Time frame: Baseline to 52 weeks
Dosage of biologics
Time frame: Baseline to 52 weeks
Blood anti-drug antibodies
Time frame: Baseline to 12 weeks
Blood adalimumab
Time frame: Baseline to 12 weeks
Micronutrient status
Time frame: Baseline to 12 weeks
Blood immunophenotype
Time frame: Baseline to 12 weeks
Self-Administered Inflammatory Bowel Disease Questionnaire
Time frame: Baseline to 12 weeks
Body Mass Index
Time frame: Baseline to 12 weeks
Body weight
Time frame: Baseline to 12 weeks
Body fat mass
Time frame: Baseline to 12 weeks
Body fat-free mass
Time frame: Baseline to 12 weeks
Handgrip strength
Time frame: Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: Yes. Participants will be asked to provide written consent for their anonymised data to be made available to public repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Enteral Nutrition in people with Crohn Disease, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Jatkowska, BSc (Hons) (07743585420, a.jatkowska.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (time frame: Baseline to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.