N/A
N=147
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Pulmonary Tuberculosis · Body Weight Changes · Motor Activity
Bottom Line
View on ClinicalTrials.gov: NCT02554318 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months — 2.80; 1.44 Kilogram
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rifampicin (Drug); Isoniazid (Drug); Pyrazinamide (Drug); Ethambutol (Drug); Fermented soybean (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Giessen
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months |
2.80; 1.44 | — |
| SECONDARY Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months |
3.90; 0.84 | — |
| SECONDARY Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months |
49.67; 25.75 | — |
| SECONDARY Change in Body Mass Index (BMI) From Baseline at 2 Months |
1.13; 0.54 | — |
Summary
Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment. This study aimed to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight and physical function changes among active pulmonary tuberculosis patients with standard therapy.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed adult male and female TB active patients
- Having clinical evidences of active TB symptoms
- Positive or negative sputum smears
- Having positive chest X-ray that compatible with a diagnosis of tuberculosis
- No history of previous anti tuberculosis treatment
- Give a written informed consent and basic contact data
Exclusion Criteria
- Heavy smoker (> 20 cigarettes per day)
- Pregnancy and lactation
- Extra pulmonary TB
- Known allergy to soybean
- Having clinical evidences of any underlying disease
Data sourced from ClinicalTrials.gov (NCT02554318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.