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Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mediterranean diet

Low residue diet

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, inflammatory bowel diseases, Mediterranean diet, microbiome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females
Age: 18-75
Diagnosis of Crohn's Disease
Montreal classification- B1
CDAI: 150-450 + CRP>0.5 or fecal calprotectin >200
Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy
Capacity to give informed consent

Exclusion Criteria:

Ileostomy or colostomy
Exclusive enteral nutrition/ partial enteral nutrition
History of or current severe systemic diseases
History of admission due to bowel obstruction
Positive Clostridium difficile toxin
Positive Salmonella, Shigella, Campylobacter, stool culture
Pregnancy or lactation
Use of antibiotics or steroids one month prior to inclusion

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.

Patients with active Crohn's disease that will be allocated to the low residue diet group.

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index (CDAI)

Change from baseline

Secondary Outcome Measures

C-reactive protein

Change from baseline

Fecal calprotectin

Change from baseline

Remission rate- CDAI<150 + normal CRP/ fecal calprotectin

Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin

Microbial composition

Full Information

NCT ID

NCT02825316

First Posted

July 4, 2016

Last Updated

July 4, 2016

Sponsor

michal roll

1. Study Identification

Unique Protocol Identification Number

NCT02825316

Brief Title

Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

Official Title

Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

michal roll

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.

Detailed Description

The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases. The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters. Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's disease, inflammatory bowel diseases, Mediterranean diet, microbiome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Patients with active Crohn's disease that will be allocated to the Mediterranean diet group.

Arm Title

Group B

Arm Type

Experimental

Arm Description

Patients with active Crohn's disease that will be allocated to the low residue diet group.

Intervention Type

Behavioral

Intervention Name(s)

Mediterranean diet

Intervention Description

Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).

Intervention Type

Behavioral

Intervention Name(s)

Low residue diet

Intervention Description

Eight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains).

Primary Outcome Measure Information:

Title

Crohn's Disease Activity Index (CDAI)

Description

Change from baseline

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

C-reactive protein

Description

Change from baseline

Time Frame

8 weeks

Title

Fecal calprotectin

Description

Change from baseline

Time Frame

8 weeks

Title

Remission rate- CDAI<150 + normal CRP/ fecal calprotectin

Time Frame

52 weeks

Title

Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin

Time Frame

8 weeks

Title

Microbial composition

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females Age: 18-75 Diagnosis of Crohn's Disease Montreal classification- B1 CDAI: 150-450 + CRP>0.5 or fecal calprotectin >200 Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy Capacity to give informed consent Exclusion Criteria: Ileostomy or colostomy Exclusive enteral nutrition/ partial enteral nutrition History of or current severe systemic diseases History of admission due to bowel obstruction Positive Clostridium difficile toxin Positive Salmonella, Shigella, Campylobacter, stool culture Pregnancy or lactation Use of antibiotics or steroids one month prior to inclusion

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lihi Godny, B.Sc

Phone

97236947305

lihigodny@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iris Dotan, MD

Organizational Affiliation

Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease

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