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A prospective follow-up study on metabolic changes in men during their spouses' pregnancy and gut microbiota characteristics of couples

A prospective follow-up study on metabolic changes in men during their spouses' pregnancy and gut microbiota characteristics of couples

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122155
Enrollment
Unknown
Registered
2026-04-09
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Metabolic syndrome

Interventions

Observation group:None

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Couples aged 20–45 years, with the female partner confirmed to have an intrauterine pregnancy. 2. Both partners provide informed consent and voluntarily agree to participate in this study. 3. Both partners possess basic Chinese reading and communication skills, and are able to cooperate with anthropometric measurements, questionnaire surveys, and faecal sample collection. 4. Male baseline body mass index (BMI) between 18.5 and 27.9 kg/m^2. 5. Enrolled in principle during early pregnancy (gestational weeks 10–14) and able to complete the follow-up in late pregnancy. 6. Neither partner has used antibiotics, probiotics, prebiotics, or other preparations that may significantly affect gut microbiota within the past month.

Exclusion criteria

Exclusion criteria: 1. Either partner suffers from a serious disease that may significantly affect metabolic status or gut microbiota, including diabetes, hypertension, dyslipidaemia, gout, thyroid dysfunction, severe cardiac, hepatic or renal diseases, inflammatory bowel disease, chronic diarrhoea, or malignant tumours. 2. The male partner has used medications that may significantly affect body weight or metabolic status within the past three months, such as glucocorticoids, weight-loss drugs, glucose-lowering agents, lipid-lowering drugs, and beta-blockers. 3. Either partner has used antibiotics, antifungals, probiotics, prebiotics, or received other interventions that may significantly affect the gut microbiota within the past month. 4. The male partner has experienced strict dieting, a systematic exercise-based weight-loss programme, or significant changes in daily routine within the past month. 5. Inability to cooperate with follow-up, questionnaire surveys, or faecal sample collection. Other conditions deemed by the investigators to make the participant unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Body Mass Index;Body weight;Waist circumference;Hip circumference;Body fat percentage;

Countries

China

Contacts

Public ContactZhou Haiyan

Xiangya Hospital, Central South University

hyzhou02@csu.edu.cn+86 186 7000 8475

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026