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Clinical Research on Biological Sample Collection by Volunteers

Clinical Research on Biological Sample Collection by Volunteers

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104379
Enrollment
Unknown
Registered
2025-06-16
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None

Interventions

Young volunteer group:NA

Sponsors

Jiangsu Province Official Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 to 30 years old (inclusive of boundary values), gender not restricted; (2) Male weight >= 50 kg, female weight >= 45 kg, BMI: calculated as weight (kg) / height^2 (m^2), within the range of 18.5 - 28 (inclusive of boundary values); (3) Blood routine, blood biochemistry, stool routine examination, and virological examination (hepatitis B, hepatitis C, HIV, syphilis) are within normal ranges or are judged by the clinical doctor as "without clinical significance" abnormalities; (4) After physical examination and vital sign examination, the clinical doctor determines that they can participate in this study; (5) Voluntarily as a volunteer and sign the informed consent form. 2. Age range: 65 years old to 100 years old (inclusive of boundary values), gender not restricted; (2) Able to take care of daily life or have basic self-care ability; (3) The age-related changes in important organs have not caused obvious functional abnormalities as judged by the researchers; (4) The risk factors affecting health have been controlled within the range appropriate for one's age, with good nutritional status; (5) Voluntary as a volunteer and have signed the informed consent form; (6) Within 4 weeks before the trial, no probiotics or antibiotics have been used; (7) Any of the above conditions not met, shall not be selected as a volunteer.

Exclusion criteria

Exclusion criteria: 1. Massive blood loss (>= 400 mL) within the previous 3 months or blood donors (interview); (2) Those with a history of fainting due to blood or needle injection, or anemia (interview); (3) Frequency of defecation within 2 weeks before the trial study: more than 3 times per day on average, or defecating once every 3 days (interview); (4) Patients with digestive system diseases, such as chronic gastroenteritis, active or repeatedly recurring gastric and duodenal ulcers, chronic pancreatitis, nonspecific ulcerative colitis. Gastrointestinal polyposis, ulcers, liver cirrhosis, malignant tumor diseases of the digestive system. As well as, digestive system symptoms such as hematochezia, constipation, abdominal distension, abdominal pain, diarrhea, jaundice (interview); (5) Those who have had acute urinary tract infections within the previous 1 year, those who have recovered from acute pyelonephritis within less than 3 months, those with urinary system stone attacks (interview); (6) Patients with allergic diseases and recurrent allergic reactions, such as frequent urticaria, bronchial asthma, drug allergies (interview); (7) Bacterial infectious diseases, patients with various tuberculosis diseases, such as pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis; parasitic diseases such as schistosomiasis, filariasis patients. As well as patients with incomplete recovery from ascariasis, pinworm infection (interview); (8) Those with positive viral tests (hepatitis B, hepatitis C, HIV, syphilis) or abnormal results of clinical significance; (9) Those who have had short-term severe infections with clinical significance as determined by the researchers within the previous 1 month, such as severe colds, chickenpox, novel coronavirus infection (interview); (10) Those who have had clinically significant diseases or undergone surgical operations within 4 weeks before the trial study (interview); (11) Those with any severe clinical disease history or with diseases of the cardiovascular system, endocrine system, nervous system, or lung and liver, hematological, immunological, psychiatric diseases, metabolic abnormalities, family genetic diseases, malignant tumor history (interview); (12) Bad living habits: heavy drinking, heavy smoking (interview); (13) Those who have taken any medication (including traditional Chinese medicine) within 2 weeks before the trial study or received vaccinations within 1 month (interview); (14) Those who have participated in any drug clinical trials within the previous 3 months (interview); (15) Those with active bleeding from hemorrhoids and inflammatory bowel diseases; (16) Other situations that the researcher deems not suitable for participating in this study. 2. Massive blood loss within 3 months before the trial study (>= 400 mL) (interview); (2) Those with a history of fainting due to blood or needle, anemia (interview); (3) Those who had suffered from a disease requiring surgical treatment within 2 weeks before the trial study (interview); (4) Those with any serious clinical disease history or with severe cardiovascular, neurological diseases, hematological, immunological, psychiatric diseases, metabolic abnormalities, hereditary diseases, or malignant tumor history (interview); (5) Those who had a history of drug abuse within 6 months before the trial study (interview); (6) Bacterial infectious diseases, patients with various tuberculosis (such as pulmonary tuberculosis, renal tub

Design outcomes

Primary

MeasureTime frame
Medical history; Lifestyle assessment (questionnaire survey);Physical examination;Vital signs;Laboratory tests;

Countries

China

Contacts

Public ContactGu Liubao

Jiangsu Province Official Hospital

abobgu@126.com+86 152 6188 4799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026