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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47019
Enrollment
56
Registered
2016-11-08
Start date
2017-01-03
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Spinal cord injury

Interventions

Sponsors

Revalidatiecentrum Heliomare
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients should be confirmed with the diagnosis of spinal cord injury (SCI), first be admidded to a rehabilitation center after the occurrence of the SCI, aged between 18 and 75 years, and requiring treatment with antibiotics.

Exclusion criteria

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 10 days - Antibiotic use of nitrofurantoin or trimethoprim, nitrofurantoine, flucloxacilline (very few to no antibiotics associated diarrhea has been shown in the general population)

Design outcomes

Primary

MeasureTime frame
Antibiotic associated diarrhoea, defined as three or more liquid stools (Bristol stool scale score 5, 6 or 7) per day for three or more days.

Secondary

MeasureTime frame
Time to reach proper bowel management, defecation frequency, faecel consistency, quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)