The ADDapt Diet in Reducing Crohn's Disease Inflammation

NCT04046913 | Unknown

• 1 other identifier: IRAS 260196
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. The prevalence of CD is 10.6 per 100,000 people in the UK and represents a significant annual financial burden of around €16.7 billion in Europe. A wide range of nutrients and food components have been investigated for their role in the pathogenesis and course of CD. A common theme suggests that CD risk is associated with a "Western diet", including high fat, high sugar and processed foods. However, intervention studies that exclude specific aspects of the diet such as sugar or that compare low and high fat diets have failed to show effectiveness in practice. Observational human and experimental animal studies suggest that certain food additives used extensively by the food industry play a role in the pathogenesis and natural history of CD. However, to date no evidence exists for the effectiveness of a diet low in these food additives in CD. Therefore, the aim of this study is to investigate the effects of a diet low in certain food additives compared to a normal UK diet on CD activity, health-related quality of life, gut bacteria, gut permeability, gut inflammation and dietary intake, in patients with mildly active, stable CD. We will recruit patients with mildly active CD and will randomise them to receive either the diet low in the food additives of interest, or the diet representative of a normal UK diet. Patients will follow their allocation diet for 8 weeks and will attend study visits at the start and end of the trial, at which points questionnaires will be completed and samples will be collected.

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Keywords

Dietary intervention

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index

  The proportion of patients achieving at least a 70-point reduction in the Crohn's Disease Activity Index from baseline to week 8

  Difference between baseline and week 8

Secondary Outcomes (22)

• Faecal calprotectin

  Baseline, 8 weeks and 26 weeks

• Faecal calprotectin

  Baseline, 8 weeks and 26 weeks

• Faecal calprotectin

  Baseline, 8 weeks and 26 weeks

• Serum C-reactive protein

  Baseline, 8 weeks and 26 weeks

• Mucosal immune cell gene expression

  Baseline and 8 weeks

Study Arms (2)

Low food additive diet

ACTIVE COMPARATOR

Dietary advice, given by a dietitian, will be discussed at trial baseline.

Behavioral: Dietary education

Habitual food additive diet

PLACEBO COMPARATOR

Dietary advice, given by a dietitian, will be discussed at trial baseline.

Behavioral: Dietary education

Interventions

Dietary education BEHAVIORAL

Intervention: Low food additive diet. Control: Habitual food additive diet

Habitual food additive diet; Low food additive diet

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥16 years
• CD diagnosis (defined by standard clinical, histological and radiological criteria) of at least 3 months
• Mildly active disease as defined by:
• Defined by physician assessment that no change in medication is required
• Faecal calprotectin \>150 µg/g OR endoscopic evidence of active luminal disease OR radiological evidence of active luminal disease (by magnetic resonance enterography, or ultrasound) within the last 8 weeks.
• CDAI between 150-250
• Current body weight of ≥50 kg
• Individuals able to give informed consent and willingness to participate

You may not qualify if:

• Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-α agents or other biologics during the preceding 8 weeks, oral 5-ASA during the preceding four weeks. Currently receiving oral prednisolone/budesonide or discontinued within the last 4 weeks, unless they are on a stable dose of 10 mg/day or less prednisolone (3 mg or less budesonide) for at least 4 weeks with the intention to continue this long term.
• Used rectal 5-ASA or rectal steroids in the preceding 4 weeks
• Previous extensive bowel resection, defined as having had \>2 intestinal resections, a sub-total colectomy or documented short bowel syndrome
• Poorly controlled bile acid malabsorption
• Current stoma
• Recent use of the following treatments: antibiotics, probiotics, prebiotic or fibre supplements in the preceding four weeks, NSAIDs during the preceding week
• Full bowel preparation for a diagnostic procedure in preceding 4 weeks
• Comorbidities including sepsis/fever, diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease
• Exclusive enteral nutrition in the past 8 weeks
• Assessed as at nutritional risk, as defined by any of the following:
• BMI ≤18.5 kg/m2
• Previous or current eating disorder
• Currently receiving prescribed oral nutritional supplements
• Following a restrictive diet (e.g. multiple restrictions due to numerous self-reported allergies) as judged by the dietitian
• Reported pregnancy or lactation

Sponsors & Collaborators

• King's College London: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Institut Pasteur: collaborator

Study Sites (1)

King's College London

London, SE1 9HN, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 6, 2019
• Study Start: September 9, 2019
• Primary Completion: April 25, 2024
• Study Completion: August 20, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-01

Locations

GB (1)