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Applying Manuka Honey in Gastroenterology

Withdrawn
Conditions
Diarrhea
10017966
10004018
Registration Number
NL-OMON45863
Lead Sponsor
TweeSteden ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

All patients seen at the outpatient clinic in either Elisabeth-TweeSteden Hospital in Tilburg, or the Maastricht University Medical Center with any of the following diagnoses will be eligible for inclusion: ;1. Patients with a persistent clostridium difficile infection who either do not respond to antibiotic therapy or do not tolerate antibiotics;2. Patients with diagnosed microscopic colitis who have received maximum budesonide treatment, and experience relapse of symptoms during step-down dosages, defined as budesonide dependent microscopic colitis ;3. Patients diagnose with irritable bowel syndrome patients of diarrhea subtype according to the Rome IV criteria, whose symptoms persist despite 6 months of treatment via the outpatient clinic ;- Therapy refractory defined as patients with a definitive diagnosis who continue to have a defecation frequency above 3 times daily, with at least one of these times a consistency of 5 or 6 according to the Bristol Stool Scale. ;- A minimum of 1 year follow up;- Age older than 18 years old at diagnosis

Exclusion Criteria

- Patients younger than 18 years of age ;- Comorbidities of gastro-intestinal tract;- Drug or alcohol abuse

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary outcome measure:<br /><br>- Frequency of stools<br /><br>- Consistency of stool as measured using the Bristol Stool Scale </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome measures<br /><br>- Recurrence of abdominal symptoms after start intervention measured using the<br /><br>Gastro-intestinal Symptom Rating Scale (GSRS)<br /><br>- Recurrance of symptoms attributed to irritable bowel disorder measured using<br /><br>the Birmingham IBS symptom questionnaire<br /><br>- Quality of life (QOL) measured using the Ferrans and Powers QOL-Index </p><br>
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