Cyclic dietary calorie and protein restriction for induction of Inflammatory Bowel Disease - Treatment Of IBD using Cyclic Dietary Intervention (TOCDI)

Academisch Medisch Centrum0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•- 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.

•- 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

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