Study of interactions between intestinal microflora, intestinal macrofauna and antibiotic use in adults living in Lambaréné, Gabo

Not Applicable

• Conditions: Digestive System; Gut Flora and fauna

• Registration Number: PACTR201707002361207
• Lead Sponsor: Centre de Recherches Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital Lambaréné, Gabon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

¿Healthy males or females between the ages of 21 and 40 years
¿Participants colonized with either Trichuris trichura or Ascaris lumbricoides; or co-infection both within a +/- 25% interval parasite load
¿Negative for HIV, HBV and HCV serology.
¿Body mass index between 18 and 30
¿Ability to understand and provide written informed consent
¿Willingness to reside within the study area for the entire study duration (6 months)

Exclusion Criteria

¿Pregnancy as determined by a positive urine hCG (if female).
¿Currently lactating and breast-feeding (if female).
¿Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies
¿Serologic positivity for HIV, Hepatitis B or Hepatitis C
¿History of vertigo, tinnitus or hearing loss
¿Laboratory evidence of renal disease (serum creatinin greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing).
¿Body Mass Index greater than or equal to 30 or less than or equal to 18
¿Vital signs outside of acceptable range at Screening Visit (i.e., blood pressure >160/100, axillary temperature >38°C)
¿History of active uncontrolled gastrointestinal disorders or diseases
¿Chronic and or recurrent diarrhoea (diarrhoea defined as ¿ 3 loose stools per day)
¿Chronic and or recurrent constipation
¿Use of any of the following drugs within the last 1 months: antibiotics, antifungals, antivirals or antihelminthics (intravenous, intramuscular, or oral)
¿Any on-going bacteraemia or pathogenic bacteria identified in stool culture
¿Positive for Schistosoma spp,and S. Stercoralis
¿Positive for filariasis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microscopic faecal parasite eggs counts of intestinal helminths will be determined at day 0 and day 30 using Kato-Katz faecal thick smear exams (eggs per gram of faeces).