NCT02858557

Brief Summary

This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 28, 2016

Last Update Submit

August 5, 2016

Conditions

Inflammatory Bowel DiseasesCrohn's DiseaseDietary Modification

Outcome Measures

Primary Outcomes (1)

  • Microbial diversity

    Shannon α-diversity index

    7 days

Secondary Outcomes (5)

  • Clinical score

    7 days

  • C-reactive protein (CRP)

    7 days

  • fecal calprotectin

    7 days

  • Quality of life

    7 days

  • Microbial composition

    7 days

Study Arms (2)

Group A

EXPERIMENTAL

Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet

Behavioral: Mediterranean dietBehavioral: Specific Carbohydrate Diet

Group B

EXPERIMENTAL

Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet

Behavioral: Mediterranean dietBehavioral: Specific Carbohydrate Diet

Interventions

Mediterranean dietBEHAVIORAL

The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats.

Group AGroup B
Specific Carbohydrate DietBEHAVIORAL

The specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides.

Group AGroup B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75;
  • Able and willing to sign an informed consent;
  • Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Iris Dotan, MD

    Head, IBD center, Department of gastroenterology and liver diseases, Tel Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihi Godny, B.Sc

CONTACT

+9723947305lihig@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 8, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)