---
title: Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease
nct_id: NCT04305535
overall_status: UNKNOWN
phase: NA
sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
study_type: INTERVENTIONAL
primary_condition: Crohn Disease
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04305535.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04305535"
ct_last_update_post_date: 2020-03-12
last_seen_at: "2026-05-12T06:00:42.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease

**Official Title:** Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease

**NCT ID:** [NCT04305535](https://clinicaltrials.gov/study/NCT04305535)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 162
- **Lead Sponsor:** Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- **Collaborators:** Adventia Pharma, Biopolis S.L.
- **Conditions:** Crohn Disease, Absorption; Disorder, Protein, Absorption; Disorder, Absorption; Disorder, Fat, Absorption; Disorder, Carbohydrate, Malnutrition
- **Start Date:** 2020-02-13
- **Completion Date:** 2021-06
- **CT.gov Last Update:** 2020-03-12

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **Peptidic+Probiotic** (ACTIVE_COMPARATOR) — Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and mix of probiotics during 6 months
- **Peptidic+Placebo** (ACTIVE_COMPARATOR) — Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months
- **Polymeric+Placebo** (PLACEBO_COMPARATOR) — Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months

## Interventions

- **Peptidic+Probiotic** (DIETARY_SUPPLEMENT) — 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
- **Peptidic+Placebo** (DIETARY_SUPPLEMENT) — Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
- **Polymeric+Placebo** (DIETARY_SUPPLEMENT) — Polymeric oral nutritional supplement and a placebo

## Primary Outcomes

- **Malabsorption** _(time frame: 6 months)_ — Body Weight Change (kg)

## Secondary Outcomes

- **Changes in the consistency of the stools according to Bristol scale.** _(time frame: 6 months)_
- **Fat malabsorption** _(time frame: 6 months)_

## Locations (1)

- Miguel Aganzo Yeves, Madrid, Spain — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.miguel aganzo yeves|madrid||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04305535.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04305535*  
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