Effects of MUTAFLOR® on dysfunction of the gut after physical exercise

Effects of MUTAFLOR® on exercise-induced gastro-intestinal dysfunction - MEGI-1

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000573-20-DE

Enrollment

Registered

2016-04-26

Start date

2016-06-14

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

To investigate the effects of Mutaflor® Suspension on exercise induced gastrointestinal symptoms for 3 hours after a strenous exercise test on a treadmill

Interventions

Trade Name: MUTAFLOR® Suspension Pharmaceutical Form: Oral suspension

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Eligible subjects will be healthy, non-smoking males between 18 and 35 years, physically fit but not over-trained, with a BMI between 18.5 and 25 kg/m2, a maximum oxygen uptake (VO2max) of less than 53 ml/kg·min, with medically approved unrestricted sports participation as shown by diagnostic performance test conducted on bicycle no longer than 3 months prior to study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects who meet one or more of the following criteria will disqualify for study entry: 1. Weekly training volume = 3 hours 2. Use of dietary supplements (incl. high-dosed vitamins and minerals) 3. Chronic immune deficiency 4. Current infection 5. Heart and/or circulation disorders 6. Abnormal findings on exercise ECG 7. Musculoskeletal disorders 8. Any current clinical condition that requires systemic treatment or might have an impact on study objectives 9. Hypersensitivity to ingredients of Mutaflor Suspension 10. Illicit drug or alcohol abuse 11. Participation in another clinical trial within 4 weeks prior to study entry

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of Mutaflor® Suspension on exercise induced pertubation of the gastrointestinal tract as shown by the biomarkers Zonulin and LPS for 3 hours after a strenous exercise test on a treadmill ;Secondary Objective: To investigate the effects of Mutaflor® Suspension with regard to exercise induced gastrointestinal integrity (1 laboratory marker) LPS-Clearance (2 laboratory markers) gastrointestinal damage (1 laboratory marker) liver damage (2 laboratory markers) systemic, inflammatory markers (white blood cell count and 7 further laboratory markers) subjective gastrointestinal symptoms (questionnaire score) for 3 hours after a strenous treadmill test;Primary end point(s): 3-hour post-exercise levels of LPS 3-hour post-exercise levels of Zonulin ;Timepoint(s) of evaluation of this end point: Each laboratory parameter measured immediately at the end of the exercise test as well as three hours thereafter. Baseline values will be captured immediately before the exercise test.	—

Measure

Time frame

Main Objective: To investigate the effects of Mutaflor® Suspension on exercise induced pertubation of the gastrointestinal tract as shown by the biomarkers Zonulin and LPS for 3 hours after a strenous exercise test on a treadmill ;Secondary Objective: To investigate the effects of Mutaflor® Suspension with regard to exercise induced gastrointestinal integrity (1 laboratory marker) LPS-Clearance (2 laboratory markers) gastrointestinal damage (1 laboratory marker) liver damage (2 laboratory markers) systemic, inflammatory markers (white blood cell count and 7 further laboratory markers) subjective gastrointestinal symptoms (questionnaire score) for 3 hours after a strenous treadmill test;Primary end point(s): 3-hour post-exercise levels of LPS 3-hour post-exercise levels of Zonulin ;Timepoint(s) of evaluation of this end point: Each laboratory parameter measured immediately at the end of the exercise test as well as three hours thereafter. Baseline values will be captured immediately before the exercise test.

—

Secondary

Measure	Time frame
Secondary end point(s): 3-hour post-exercise levels of CLDN3 anti-LPS IgG/IgM PCSK9 I-FABP ALT AST white blood cell count Plasma Myeloperoxidase Malondialdehyd Calprotectin TNF-a IL-6 hsCRP IL-10 and additionally gi symptoms score;Timepoint(s) of evaluation of this end point: Each laboratory parameter measured immediately at the end of the exercise test as well as three hours thereafter. Baseline values will be captured immediately before the exercise test.	—

Measure

Time frame

Secondary end point(s): 3-hour post-exercise levels of CLDN3 anti-LPS IgG/IgM PCSK9 I-FABP ALT AST white blood cell count Plasma Myeloperoxidase Malondialdehyd Calprotectin TNF-a IL-6 hsCRP IL-10 and additionally gi symptoms score;Timepoint(s) of evaluation of this end point: Each laboratory parameter measured immediately at the end of the exercise test as well as three hours thereafter. Baseline values will be captured immediately before the exercise test.

—

Countries

Germany

Contacts

Public ContactHead

Ardeypharm GmbH

0049064125213

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026