Introduction of a Diet as add-on therapy for remission maintenance in IBD

Introduction of a Diet as add-on therapy for remission maintenance in IBD - Diet and IBD in remission

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46767

Enrollment

Registered

2018-02-16

Start date

2018-03-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

crohns disease inflammatory bowel disease ulcerative colitis

Interventions

Patients will enter a nutritional intervention program, coordinated by Stichting voeding leeft. Control subjects will continue their regular diet.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients with IBD in remission (fecal calprotectin (fCAL)

Exclusion criteria

Exclusion criteria: Patients unable or unwilling to provide informed consent. Stenosis associated with symptoms. Current healthy lifestyle (as there will be nothing to optimize using our nutritional intervention program).

Design outcomes

Primary

Measure	Time frame
We aim to assess the feasability of a nutritional intervention as add-on treatment (next to standard medical treatment) in patients with IBD in remission	—

Secondary

Measure	Time frame
Secondary objectives are to study the effect of the nutritional intervention program on: 1. Quality of life and Food related quality of life (FR-QoL) 2. Activity of IBD (as assessed using Harvey-Bradshaw index (HBI) or partial Mayo score (pMS) and fecal calprotectin) 3. Nutritional status and anthropometry (body weight, hand grip strength, waist-hip ratio) 4. CAP value (Fibroscan; liver fat content) 5. Immunological assessment of Th17/Treg balance in the peripheral blood of patients to assess effect of our lifestyle intervention program on the pro-inflammatory / anti-inflammatory balance in the peripheral blood of patients And in a subset of patients: 6. AGE reader	—

Measure

Time frame

Secondary objectives are to study the effect of the nutritional intervention program on: 1. Quality of life and Food related quality of life (FR-QoL) 2. Activity of IBD (as assessed using Harvey-Bradshaw index (HBI) or partial Mayo score (pMS) and fecal calprotectin) 3. Nutritional status and anthropometry (body weight, hand grip strength, waist-hip ratio) 4. CAP value (Fibroscan; liver fat content) 5. Immunological assessment of Th17/Treg balance in the peripheral blood of patients to assess effect of our lifestyle intervention program on the pro-inflammatory / anti-inflammatory balance in the peripheral blood of patients And in a subset of patients: 6. AGE reader

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)