Clinical trial NCT06139744: Efficacy and Safety of Dietary Supplementation of Diamine Oxidase to Improve Symptoms in Patients With IBS
Official title: Efficacy and Safety of Dietary Supplementation of Diamine Oxidase (DAO) to Improve Symptoms in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a single center, randomized, controlled clinical trial evaluating the effects of DAO enzyme dietary supplement on symptoms of irritable bowel syndrome.

These participants are randomized to either a 4-week group with DAO enzyme dietary supplement or placebo. The participants are required to fill out IBS-SSS and IBS-QOL questionnaires and record their IBS symptom improvement, IBS treatment drug use, compliance and adverse reactions every evening. At the same time, the patients' diet is continuously recorded for 3 days by 24-hour diet review method in Visit 0, Visit 1 and Visit 2, respectively, to inform the patients to avoid large fluctuations in diet structure. On days 0, 14 and 28, the subjects are asked to visit the hospital offline. The staff check with the subjects in detail according to the scale and questionnaire contents, and review the general situation and questionnaire in the previous 2 weeks. On the 7th and 21st day, the staff contact the subjects online to provide guidance and remind the subjects to fill in the scale and questionnaire. In addition, oral mucosal samples, urine and feces will be collected for identifying mutations in the genetic DAO enzyme coding gene, histamine detection and 16sRNA sequencing, respectively.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years old;
2. Diagnosed with IBS according to Rome IV diagnostic criteria; Recurrent abdominal pain occurred on an average of at least 1 day per week in the past 3 months and was associated with two or more of the following criteria: i. Related to defecation; ii. Associated with changes in bowel frequency; iii. Correlated with fecal morphological changes. The symptoms appeared at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months.
3. Voluntarily participate in the experiment and sign the informed consent.

Exclusion Criteria:

1. Patients with endoscopy examinations which suggest chronic intestinal diseases other than IBS, such as inflammatory bowel disease, celiac disease, gastric and duodenal ulcers, parasitic or bacterial intestinal infections;
2. Pregnant and lactating women;
3. Patients suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease, tumor;
4. Alcoholism.

Primary outcomes:
measure: IBS-SSS
timeFrame: 4 weeks of study medication administration
Secondary outcomes:
measure: IBS-QOL
timeFrame: 4 weeks of study medication administration
measure: Improvement of symptoms listed in the Rome IV diagnostic criteria for IBS
timeFrame: 4 weeks of study medication administration
Other outcomes:
measure: Effect of diet difference on treatment of IBS with dehydrated pea seedling powder
timeFrame: 4 weeks of study medication administration
measure: Histamine concentration in urine
timeFrame: 4 weeks of study medication administration
measure: Fecal intestinal flora
timeFrame: 4 weeks of study medication administration
measure: The expression of diamine oxidase in IBS patients
timeFrame: before study medication administration
measure: Drug use in subjects
timeFrame: 4 weeks of study medication administration
measure: Adverse events
timeFrame: 4 weeks of study medication administration
Locations:
city: Nanjing
country: China
facility: Zhenyu Zhang
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhenyu Zhang
role: PRINCIPAL_INVESTIGATOR
References: