Absorption; Disorder, Absorption; Disorder, Carbohydrate, Absorption; Disorder, Fat, Absorption; Disorder, Protein, Crohn Disease, Malnutrition
Conditions
Keywords
Oligomeric diet, Peptidic diet, Probiotics, Oral Nutritional Supplements
Brief summary
This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.
Detailed description
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption
Interventions
DIETARY_SUPPLEMENTPeptidic+Probiotic
Oligomeric oral nutritional supplement (Bi1 peptidic) and a mix of probiotics * Bifidobacterium animalis subsp. lactis BPL1, * Lactobacillus rhamnosus BPL15, * Lactobacillus rhamnosus CNCM i-4036 * Bifidobacterium longum ES1
DIETARY_SUPPLEMENTPeptidic+Placebo
Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
DIETARY_SUPPLEMENTPolymeric+Placebo
Polymeric oral nutritional supplement and a placebo
Sponsors
Adventia Pharma
Biopolis S.L.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food. * Willing to comply with the prescribed diet follow-up for CD.
Exclusion criteria
* Having received antibiotics in the previous 3 months * Having undergone intestinal resection surgery≥70-75% * Refuse to participate in the study * Comorbidity that allows to suspect survival \<1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malabsorption | 6 months | Body Weight Change (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the consistency of the stools according to Bristol scale. | 6 months | Bristol scale: type 1= separate hard lumps, type 2= sausage shaped but lumpy, type 3= like a sausage but with cracks on ots surface, type 4= like a sausage or sanake, smooth and soft, type 5= soft blobs with clear cut-edges, type 6= fluffy pieces with ragged edges, a mushy stool, type 7 = watery, no solid pieces. |
| Fat malabsorption | 6 months | Presence of fat in the stool |
Countries
Spain
Contacts
Primary ContactMiguel A Aganzo-Yeves, RD
Outcome results
None listed