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Effect of probiotics on bowel management in SCI

Effect of a multispecies probiotic on bowel management in patients with spinal cord injury after use of antibiotics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21378
Enrollment
40
Registered
2016-04-15
Start date
2016-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Spinal cord injury Dwarslaesie Faecal incontinence Diarree Antibiotics Antibiotica Probiotics Probiotica

Interventions

Participants will be randomly assigned to receive both an antibiotic treatment and Ecologic® AAD, or an antibiotic treatment and a placebo. Subjects will receive either probiotic or placebo for 26-31
5-10 days)
starting together with the antibiotic treatment and ending three weeks after cessation.

Sponsors

Heliomare Rehabiliation Wijk aan Zee Reade Center for Rehabilitation and Rheumatology Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis of SCI - First admission to a rehabilitation center after the occurrence of SCI. - Age between 18-75 years - Requiring treatment with antibiotics

Exclusion criteria

Exclusion criteria: - Known gastro-intestinal diseases - Abdominal surgery within a year prior to study - (Previous) radiotherapy or chemotherapy - Severe auto immune diseases such as SLE and Sjogren - Patients suffering from severe acute pancreatitis, multiple organ failure (MOF) or sepsis - Patients receiving enteral feeding with the exception of nasogastric feeding - Excessive alcohol intake (> 15 consumptions per week) - (Planned) pregnancy or lactation - Use of pre-, probiotics in the month before and during the study - Use of antibiotics in the two weeks before the study - More than one antibiotic treatment in the 6 month prior to the study. - Previous participation in this study design - Duration of antibiotics use longer than 14 days

Design outcomes

Primary

MeasureTime frame
Incidence of faecal incontinence, defined by frequency, consistency, (un)wanted defecation, measured by the Bristol Stool Scale.

Secondary

MeasureTime frame
Quality of life, nausea.

Contacts

Public ContactMaaike Eken

Relweg 51

m.eken@heliomare.nl+31 (0) 88 - 920 8013

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)