JMIR Publications

ABSTRACT

Background:

The gut microbiome is an important component of human physiology and is involved in immune regulation, metabolism, and communication along the gut–brain axis. Perioperative factors, including surgery, fasting, medications, and anesthetic exposure, may alter the intestinal microbiome and metabolome. Evidence in children undergoing surgery is limited.

Objective:

The primary objective is to evaluate changes in gut microbiota composition and fecal metabolic profiles between baseline (approximately 24 hours before surgery) and postoperative day 7 in children undergoing elective surgery under general anesthesia. The secondary objective is to assess cognitive function at baseline, 48 hours, and postoperative day 7 and explore associations between microbiome/metabolome changes and cognitive trajectories.

Objective:

The primary objective is to evaluate changes in gut microbiota composition and fecal metabolic profiles between baseline (approximately 24 hours before surgery) and postoperative day 7 in children undergoing elective surgery under general anesthesia. The secondary objective is to assess cognitive function at baseline, 48 hours, and postoperative day 7 and explore associations between microbiome/metabolome changes and cognitive trajectories.

Methods:

This prospective, single-center observational study will enroll 100 children aged 4–15 years undergoing elective surgery expected to last more than 60 minutes under general anesthesia at AIIMS, New Delhi. Eligible participants will undergo baseline stool collection and cognitive assessment before surgery, documentation of perioperative clinical and anesthetic exposures, and postoperative stool collection and cognitive assessment. Whole-genome shotgun metagenomic sequencing will be used to characterize the gut microbial community and functional potential using the sequencing and bioinformatic workflow described in the study protocol. Fecal metabolomic profiling will be performed using the study laboratory's validated LC–MS workflow. Cognitive function will be assessed using the Seguin Form Board Test for children aged 4–6 years and Malin’s Intelligence Scale for Indian Children for children aged 6–15 years. Longitudinal microbiome, metabolomic, and cognitive data will be analyzed using appropriate within-participant and multivariable methods.

Results:

Results:

The study is ongoing within the planned 3-year study period (2024–2027). The protocol was registered with the Clinical Trials Registry–India (CTRI/2024/03/063431) on March 1, 2024, and received Institutional Ethics Committee approval at AIIMS, New Delhi (IEC-659/06.10.2023). Recruitment and follow-up are ongoing.

Conclusions:

This protocol will characterize perioperative changes in gut microbiota and fecal metabolites and examine their relationship with postoperative cognitive function in children. The study may provide preliminary clinical evidence to guide future research on the gut–brain axis and pediatric perioperative recovery. Clinical Trial: Clinical Trials Registry–India (CTRI/2024/03/063431); registered March 1, 2024.