High fibre diet and low dose lincomycin for chronic constipation

ISRCTN ISRCTN33023013
DOI https://doi.org/10.1186/ISRCTN33023013
Secondary identifying numbers N/A
Submission date
13/01/2011
Registration date
16/02/2011
Last edited
16/02/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Luis Maria Bustos Fernandez
Scientific

Echeverria 2771
CABA
1428
Argentina

Email lbustos@arnetbiz.com.ar

Study information

Study designRandomised double-blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA controlled pilot study on the efficacy of a high fibre diet and a low dose lincomycin for chronic constipation
Study objectivesAssess the synergistic short term, low dose, preparatory action of a poorly absorbable antibiotic on chronic constipated patients on a high fibre diet.
Ethics approval(s)This was a very small pilot observational study started in 1996 and finalised 1 year later. At the time of this pilot study, there was an exogenous improvised board named simply by the principal investigator and the ethics board that met gave only verbal approval. Since then, this board has dissolved and unfortunately records are not available.
Health condition(s) or problem(s) studiedChronic constipation
InterventionThe study design determined a 15-day run-in phase without any drug or rescue laxatives and a 21-day controlled treatment period. On the first day of the controlled treatments period (Day 0) enrolled patients were randomised to an initial 10 day low dose lincomycin (0.5 g/d) or to placebo. During the 21 day treatment period, the diet of all patients was supplemented by 12 g of crude fibre (All Bran Kellog).

Patients were assigned a number on accordance to a validated 10 point Visual Analogue Scale (VAS) of symptom severity (0 = very severe, 10 = asymptomatic). Post-hoc, we examined the proportion of patients that exhibited marked improvement in the efficacy parameters after the 21 day treatments.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Lincomycin
Primary outcome measureDifference between treatments in the mean bowel frequency, straining, stool consistency and pain during defecation at baseline (Day 0) and by the end of treatment period (Day 21).
Secondary outcome measuresNo secondary outcome measures
Overall study start date05/09/1996
Completion date15/04/1997

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30 patients
Key inclusion criteria1. Meet Rome II diagnostic criteria for chronic constipation characterised by:
1.1. A frequency of less than or equal to two bowel movements/week
1.2. Hard stool
1.3. Straining with occasional pain in more than 25% of bowel movements
2. Aged over 18 years, either sex
Key exclusion criteria1. Cardiac, pulmonary, renal, liver failure
2. Abnormal blood chemistries
3. Known antibiotic allergies

In patients who were younger than 50 years and had no other complaint than chronic constipation and the physical examination and routine body chemistries were normal, it was assumed the diagnostic of functional constipation and no special gastrointestinal exams were performed. Patients greater than or equal to 50 years or with lower gastrointestinal bleeding underwent colon radiology or colonoscopy to rule out organic colorectal disease.
Date of first enrolment05/09/1996
Date of final enrolment15/04/1997

Locations

Countries of recruitment

  • Argentina

Study participating centre

Echeverria 2771
CABA
1428
Argentina

Sponsor information

Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)
Research organisation

Echeverria 2771
CABA
1428
Argentina

Email lbusto@arnetbiz.com.ar

Funders

Funder type

Research organisation

Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan