The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Location status: Recruiting
NCT Number: NCT07621367
This multicenter, randomized, double-blind, placebo-controlled clinical trial aimed to investigate the efficacy and safety of gut oxygen therapy in the treatment of ischemic-hypoxic bowel disease using deep intestinal catheterization as a targeted route for gut oxygen delivery.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210011, China
Location status: Recruiting
Subjects who met the inclusion criteria but did not meet any of the exclusion criteria were randomly assigned in a 1:1 ratio to receive 250mL of oxygen (30%-40%) or air through a deep intestinal catheterization four times a day for 5 days. The data of core symptoms (abdominal pain, abdominal distension, defecation), intestinal motility, vital signs and test results before and after treatment were collected to evaluate the efficacy and safety of gut oxygen therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days.
Patients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.
Time frame: Five-day after intervention
The severity of core symptoms (including abdominal pain, abdominal distention, and difficult defecation) was assessed using the VAS score, which ranged from 0 to 10 for each symptom, with higher scores indicating more severe symptoms, and the total score ranged from 0 to 30.
Time frame: Five-day after intervention
The patients' satisfaction with the treatment was graded into five levels: very dissatisfied, dissatisfied, average, relatively satisfied, and very satisfied. The differences of treatment satisfaction among different groups were compared.
Time frame: Five-day after intervention
The number of adverse reactions reported by subjects from the start of treatment to the end of follow-up
Time frame: Baseline and 30 minutes after the last intervention on day 5
The movement frequency of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement frequency between the two groups will be compared.
Time frame: Baseline and 30 minutes after the last intervention on day 5.
The movement amplitude of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement amplitude between the two groups will be compared.
Time frame: Five-day after intervention
The 16s-RNA or meta-analysis of gut microbiota will be used.
Contact information is provided by the study sponsor or research team.
The Second Hospital of Nanjing Medical University
Other
Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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