Is cows’ "first milk" an acceptable and effective way of improving gut health and nutrition in children with Crohn’s disease?

Dietary therapy with bovine colostrum to improve nutrition and gut health in paediatric Crohn’s disease; a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78570360

Enrollment

Registered

2019-07-08

Start date

2019-02-18

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease in children Digestive System

Interventions

Young people will be randomised 1:1 to the two study arms (weeks 1-6) using a computer-generated random allocation sequence with blocks of varied size generated and held by the CTU at LSTM. A Research

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 8 years and above 2. CD in clinical remission or mild/moderate disease severity (weighted pCD Activity Index [wPCDAI] =57.5) 3. Stable clinical condition defined as either receiving no treatment or maintenance therapy that has been unchanged for at least the last 2 months with no intention to change therapy at the time of recruitment 4. Willing for clinical information to be used for the purposes of the trial 5. Willing to partake in the study procedures 6. Able to complete the daily diary in English

Exclusion criteria

Exclusion criteria: 1. Severe CD (wPCDAI >57.5) 2. Intolerance of dairy products 3. Receiving dietary therapy for the management of Crohn’s disease (e.g. Modulen IBD) 4. Already taking BC regularly 5. Established diagnosis of a significant gut disorder other than CD (e.g. short bowel syndrome) 6. Failure to obtain informed consent from the patient and/or parent/guardian

Design outcomes

Primary

Measure	Time frame
Compliance with dietary supplement recorded in a daily diary collected during weeks 2, 6 and 12 and during weekly phone calls	—

Secondary

Measure	Time frame
1. Young people’s and parent's/carers’ perceptions and views regarding dietary therapy and on participating in research on dietary therapy assessed using interviews conducted at the end of the first week, end of week 6 and after completion of the intervention by week 13-14 2. Recruitment rate assessed using the number of screened young people who participate in the study 3. Retention rate assessed using the number of screened young people who complete the study 4. Acceptability and feasibility of the sugar permeability test and collection of stool, urine and blood samples assessed using the number of participating young people who provide samples of blood, stool and urine at baseline and 6 and 12 weeks 5. Intestinal inflammation assessed using calprotectin level in stool samples measured using ELISA at baseline, 6 and 12 weeks 6. Intestinal permeability assessed using urinary concentrations of lactulose, rhamnose and mannitol following oral administration, blood concentrations of endotoxin antibodies and intestinal fatty acid binding protein and faecal a1-antitrypsin measured using ELISA at baseline, 6 and 12 weeks 7. Systemic inflammation assessed using serum C-reactive protein level, erythrocyte sedimentation rate, a-1 acid glycoprotein level, cytokine assay (multiplex method) and blood platelets measured by haematology analyser at baseline, 6 and 12 weeks 8. Serum levels of growth factors, including insulin-like growth factor (IGF)-1 and IGF binding protein-3, measured using ELISA at baseline, 6 and 12 weeks 9. Disease activity measured using the weighted paediatric Crohn’s Disease Activity Index at baseline, 6 and 12 weeks 10. Quality of life assessed using a paediatric inflammatory bowel disease disease-specific health-related quality of life instrument - the IMPACT III questionnaire - at baseline, 6 and 12 weeks	—

Measure

Time frame

1. Young people’s and parent's/carers’ perceptions and views regarding dietary therapy and on participating in research on dietary therapy assessed using interviews conducted at the end of the first week, end of week 6 and after completion of the intervention by week 13-14 2. Recruitment rate assessed using the number of screened young people who participate in the study 3. Retention rate assessed using the number of screened young people who complete the study 4. Acceptability and feasibility of the sugar permeability test and collection of stool, urine and blood samples assessed using the number of participating young people who provide samples of blood, stool and urine at baseline and 6 and 12 weeks 5. Intestinal inflammation assessed using calprotectin level in stool samples measured using ELISA at baseline, 6 and 12 weeks 6. Intestinal permeability assessed using urinary concentrations of lactulose, rhamnose and mannitol following oral administration, blood concentrations of endotoxin antibodies and intestinal fatty acid binding protein and faecal a1-antitrypsin measured using ELISA at baseline, 6 and 12 weeks 7. Systemic inflammation assessed using serum C-reactive protein level, erythrocyte sedimentation rate, a-1 acid glycoprotein level, cytokine assay (multiplex method) and blood platelets measured by haematology analyser at baseline, 6 and 12 weeks 8. Serum levels of growth factors, including insulin-like growth factor (IGF)-1 and IGF binding protein-3, measured using ELISA at baseline, 6 and 12 weeks 9. Disease activity measured using the weighted paediatric Crohn’s Disease Activity Index at baseline, 6 and 12 weeks 10. Quality of life assessed using a paediatric inflammatory bowel disease disease-specific health-related quality of life instrument - the IMPACT III questionnaire - at baseline, 6 and 12 weeks

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026