Cyclic dietary calorie and protein restriction for induction of Inflammatory Bowel Disease

Recruiting

• Conditions: inflammation of the gastrointestinal tract; inflammatory disease; 10017969

• Registration Number: NL-OMON50395
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- In the opinion of the investigator, the subject is capable of understanding
and complying with protocol requirements.
- The subjects signs and dates a written, informed consent form and any
required privacy authorization prior to the initiation of any study procedures.
- Crohn*s disease or Ulcerative colitis
- Active mild to moderate disease (defined as an endoscopic SES-CD score >= 6 or
in case of exclusive ileal disease >= 4, after ileocoecal resection a Rutgeert*
score >= i2 and a HBI score between 5 and 10) or in case of UC a Mayo
endoscopic sub score >= 1 with a Full MAYO-score between 4 and 9)
- Age between 18 - 70 years at baseline
- In the opinion of the investigator, the subject is capable of understanding
in reading and speaking the Dutch language and complying with protocol
requirements.

Exclusion Criteria

- BMI: <18.5, >35
- Weight loss of >5% within one month or >10% within 6 months prior to the study
- Use of pro- and antibiotics in 6 weeks prior to start of the study
- Known allergy/intolerance to any of the ingredients in the diets
- Known malignancy or dysplasia
- Pregnancy, lactation
-Risk of malnutrition as determined by renal insufficiency, renal or
electrolyte abnormality (serum creatinine >2 × upper limit of normal (ULN);
eGFR < 30 mL/min Serum potassium outside the 3,5 - 5,0 mmol/l range and serum
sodium outside the 135 - 145 mmol/l range)
- Presence of toxins or other signs of infectious agents in stool sample
(i.e. clostridium, salmonella, shigella, yersinia or campylobacter)
- Any other condition or comorbidity which in the opinion of the investigator
would make the patient unsuitable for enrollment, or could interfere with the
patient participating in and completing the study.
- Insulin-dependent diabetes mellitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Remission induction (4 weeks of dietary intervention)<br /><br>- Proportion of patients with clinical remission after 4 weeks of dietary<br /><br>intervention. Clinical remission will be defined as a Harvey Bradshaw Index<br /><br>(HBI) < 5. </p><br>