Efficacy and Safety of Dietary Supplementation of Diamine Oxidase to Improve Symptoms in Patients With IBS

Irritable Bowel Syndrome (IBS) Clinical Trial

Official title:

Efficacy and Safety of Dietary Supplementation of Diamine Oxidase (DAO) to Improve Symptoms in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139744
• Other study ID #: KY20230915-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2023
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Zhenyu Zhang
• Phone: 02552271029
• Email: ahzhangzhenyu[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

Intervention

Drug:
• DAO supplement
One tablet of the supplementary study product is taken orally before morning, lunch and dinner every day, and each tablet contains 4.2mg of dehydrated pea seedling powder.
• Placebo
Placebo is orally supplemented with one tablet each day before morning, lunch and dinner, and placebo does not contain dehydrated pea seedling powder 4.2mg.

Locations

Country	Name	City	State
China	Zhenyu Zhang	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of diet difference on treatment of IBS with dehydrated pea seedling powder	The effects of dietary differences on the treatment of IBS with dehydrated pea seedling powder were evaluated by 24-hour diet review.	4 weeks of study medication administration
Other	Histamine concentration in urine	The effect of dehydrated pea seedling powder on histamine concentration was evaluated by detecting histamine concentration in urine.	4 weeks of study medication administration
Other	Fecal intestinal flora	Changes of fecal intestinal flora in patients before and after oral administration of dehydrated pea seedling powder	4 weeks of study medication administration
Other	The expression of diamine oxidase in IBS patients	The expression of diamine oxidase in IBS patients	before study medication administration
Other	Drug use in subjects	The effects of dehydrated pea seedling powder interventions on drug use in subjects	4 weeks of study medication administration
Other	Adverse events	The occurrence of adverse events	4 weeks of study medication administration
Primary	IBS-SSS	The effects of DAO enzyme dietary supplement from dehydrated pea seedling powder on IBS symptoms were evaluated by the Severity Scale of irritable bowel Syndrome (IBS-SSS) and the changes of several independent symptoms.	4 weeks of study medication administration
Secondary	IBS-QOL	The overall improvement of quality of life in IBS patients with DAO enzyme dietary supplement from dehydrated pea seedling powder was evaluated by the irritable bowel Syndrome Quality of Life Questionnaire (IBS-QOL).	4 weeks of study medication administration
Secondary	Improvement of symptoms listed in the Rome IV diagnostic criteria for IBS	Number of days with abdominal pain in the past week; Number of days of defecation-related abdominal pain in the past week; Frequency of bowel movements; Changes in stool pattern according to the Bristol stool Classification Scale.	4 weeks of study medication administration