Randomized, placebo-controlled study on the influence of Silica on stress-induced increased permeablity in patients with gastrointestinal symptoms

Not Applicable

• Conditions: K58; Irritable bowel syndrome

• Registration Number: DRKS00009545
• Lead Sponsor: STZ 1172 Gesundheitsförderung und Stoffwechselforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-26
• Study Completion: 2016-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

anamnestisch evidence runners diarrhea or GIQLI=112 or irritable bowel symptom of diarrhea type
- Age between 18-65 years
- Written consent present
- Sufficient exercise capacity and regular exercise about 3-4 training sessions / week with a duration of 30-60 minutes at a moderate intensity.

Exclusion Criteria

- Presence of disease that affect the gastrointestinal condition or physical fitness (anamnestic or laboratory abnormalities)
-Chronic intake of NSAIDs or steroids
-Lactose intolerance
-Chronic Inflammatory bowel disease
-Zoeliakie
-Maligne Disease within the last 5 years
-antibiotics Therapy in the past 4 weeks
- drug addiction
- Pregnancy
- Food allergy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in intestinal permeability during physical stress by taking Silicea compared to placebo, which is estimated by the analyzed concentration of Zonulin in the faeces after exercise and test of gastrointestinal permeability (5 hour test)

Secondary Outcome Measures

Name	Time	Method
Change in bowel frequency and the change of gastrointestinal quality of life (GQLI)