NCT04526613Befejeződött
The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
A Cross-Sectional Study to Estimate the Influence of Malnutrition, Diabetes Mellitus and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 12.
Rövid összefoglaló (regiszter, angolul)
About 2 billion people worldwide are infected with tuberculosis (TB). Ninety percent of those people have latent TB infection (LTBI). Risk factors like malnutrition, diabetes mellitus (DM), and helminth infection can affect the development of active TB. Researchers want to study LTBI individuals with these issues to see how they may contribute to a person s higher risk for developing active TB. This study will take place in Chennai, India. Objective: To estimate the prevalence of malnutrition, DM, and helminth infections in people with LTBI. Eligibility: People age 14 65 with or without LTBI. Design: Participants will be screened with a medical history and physical exam focused on symptoms of active TB. Those who have TB symptoms will not take part in the study. Those who do not have TB symptoms will have a physical exam with vital signs, height, and weight. They will give blood and stool samples. Participants will be assigned to 1 of 6 groups. They will repeat some of the screening tests. They will give urine samples. Some groups will have a chest X-ray. Some groups will have an ultrasound of the abdomen. Participants will complete a survey about their history of smoking and drug and alcohol use. Participants will have data collected about their nutritional status and body composition. Their skinfold thickness, ratio of waist/hip circumference, and grip strength will be measured. Participants with DM, malnutrition, or helminth infection will be given standard of care or referred for follow-up treatment. Participation will last up to 6 months. ...
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 626 (tényleges)
- Első benyújtás
- 2020. aug. 25.
- Kezdés
- 2021. ápr. 19.
- Elsődleges befejezés
- 2026. márc. 11.
- Fő szponzor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT04526613
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 626
- 2021. ápr. 19. és az elsődleges befejezés (2026. márc. 11.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- PARTICIPANT INCLUSION CRITERIA (Screening Phase)
- Individuals who meet the following criteria are eligible to participate in the screening phase:
- Aged 14 to 65 years.
- Willingness to provide blood, urine, and stool samples for examination.
- Willingness to have samples and data stored.
- Able to provide informed consent.
- PARTICIPANT EXCLUSION CRITERIA (Screening Phase)
- Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
- Two IGRA tests with indeterminate results (mitogen values \<10 IU).
- PARTICIPANT INCLUSION CRITERIA (Study Phase)
- Individuals are eligible for the study phase if they meet the requirements for one of the study groups, as follows:
- LTBI+ and severe to moderate malnutrition (BMI \<17 kg/m2);
- LTBI+ and uncontrolled DM (HbA1c \>8%);
- LTBI+ and helminth infection (positive stool qPCR and/or serology);
- LTBI+ with more than one of the conditions defined in groups 1 3;
- healthy LTBI+ controls who are negative for all of the above conditions; and
- healthy LTBI-negative controls with none of the above conditions.
- PARTICIPANT EXCLUSION CRITERIA (Study Phase)
- Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
- Pregnant or lactating women.
- Previous treatment for LTBI.
- Anemia with hemoglobin \<8 g/dl (evaluated at the screening phase visit).
- For LTBI+ participants, clinically indicated chest X-ray positive for pulmonary TB.
- For malnourished participants, clinically indicated abdominal ultrasound positive for abdominal TB.
- Known documented cases of cancer, acquired immune deficiency syndrome, or other immunosuppressive illness.
- History of any other illness or condition which, in the investigator s judgment, may substantially increase the risk associated with the participant s participation in the protocol, or compromise the scientific objectives.
Életkor a regiszterben: 14 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institute for Research In Tuberculosis, International Centers for Exel Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Chennai | India | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.