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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Drug: DAO supplement; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhenyu Zhang; Phone Number: 0086 02552271029; Email: ahzhangzhenyu@sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Zhenyu Zhang
      • Contact: Zhenyu Zhang; Phone Number: 0086 02552271029; Email: ahzhangzhenyu@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAO supplement group; One tablet of the supplementary study product was taken orally before morning, lunch and dinner every day, and each tablet contained 4.2mg of dehydrated pea seedling powder.	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.; Other Names: PEA SPROUT DEHYDRATED POWDER
Placebo Comparator: Placebo group; Placebo was orally supplemented with one tablet each day before morning, lunch and dinner, and placebo did not contain dehydrated pea seedling powder 4.2mg.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
The expression of diamine oxidase in IBS patients	The expression of diamine oxidase in IBS patients	before study medication administration
Drug use in subjects	The effects of dehydrated pea seedling powder interventions on drug use in subjects	4 weeks of study medication administration
Adverse events	The occurrence of adverse events	4 weeks of study medication administration

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Zhenyu Zhang, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: KY20230915-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No