Crohn DiseaseNCT04305535
Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease
A study testing Peptidic+Probiotic in people with Crohn Disease and Absorption; Disorder, Protein, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Absorption; Disorder, Protein, Absorption; Disorder
- What is being tested?
- Peptidic+Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2020to Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Miguel Aganzo Yeves
Madrid, 28040
Miguel A Aganzo-Yeves, RD, +34661774925, miguel.aganzo@fjd.es
About this study
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
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.
Read the 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
- Conditions
- Crohn Disease, Absorption; Disorder, Protein, Absorption; Disorder, Absorption; Disorder, Fat, Absorption; Disorder, Carbohydrate, Malnutrition
- Being tested
- Peptidic+Probiotic, Peptidic+Placebo, Polymeric+Placebo
- Keywords
- Oligomeric diet, Peptidic diet, Probiotics, Oral Nutritional Supplements
- Medical subject headings
- Crohn Disease, Platelet Glycoprotein IV Deficiency, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptidic+ProbioticDietary 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+PlaceboDietary supplement
Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
Polymeric+PlaceboDietary supplement
Polymeric oral nutritional supplement and a placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Peptidic+Probiotic |
| 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 Receives: Dietary Supplement: Peptidic+Placebo |
| 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 Receives: Dietary Supplement: Polymeric+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malabsorption
Body Weight Change (kg)
Measured: 6 months
Secondary outcomes (2)
Changes in the consistency of the stools according to Bristol scale.
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.
Measured: 6 months
Fat malabsorption
Presence of fat in the stool
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start13 Feb 2020
- Primary completionFeb 2021 (estimated)
- Study completionJun 2021 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Adventia Pharma, Biopolis S.L.
- Responsible party
- Sponsor
- Investigators
- Miguel Aganzo-Yeves, RD, Principal investigator, Hospital Universitario Fundación Jiménez DíazClotilde Vázquez-Martínez, MD, Study director, Hospital Universitario Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305535
- Sponsor's protocol ID
- EC032-19_FJD
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04305535
- Acronym / sponsor ID
- EC032-19_FJD
- Conditions
- Crohn Disease, Absorption; Disorder, Protein, Absorption; Disorder, Absorption; Disorder, Fat, Absorption; Disorder, Carbohydrate, Malnutrition
- Keywords
- Oligomeric diet, Peptidic diet, Probiotics, Oral Nutritional Supplements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Adventia Pharma, Biopolis S.L.
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 Mar 2020 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peptidic+Probiotic | Active comparator | Dietary Supplement: Peptidic+ProbioticNutritional 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 | Dietary Supplement: Peptidic+PlaceboNutritional 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 | Dietary Supplement: Polymeric+PlaceboNutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Peptidic+ProbioticOligomeric 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 supplement | Peptidic+Probiotic |
| Peptidic+PlaceboOligomeric oral nutritional supplement (Bi1 peptidic) and a placebo | Dietary supplement | Peptidic+Placebo |
| Polymeric+PlaceboPolymeric oral nutritional supplement and a placebo | Dietary supplement | Polymeric+Placebo |
Primary outcome
Malabsorption
Time frame: 6 months
Body Weight Change (kg)
2 secondary outcomes
Changes in the consistency of the stools according to Bristol scale.
Time frame: 6 months
Fat malabsorption
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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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.
Miguel Aganzo-Yeves, RD principal investigator
Hospital Universitario Fundación Jiménez Díaz
Clotilde Vázquez-Martínez, MD study director
Hospital Universitario Fundación Jiménez Díaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptidic+Probiotic in people with Crohn Disease and Absorption; Disorder, Protein, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 2 inclusion and 4 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. Some participants in this study may receive a placebo. 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 Miguel A Aganzo-Yeves, RD (+34661774925, miguel.aganzo@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malabsorption (time frame: 6 months). 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 12 Mar 2020.