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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAO supplement group | Experimental | 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. |
|
| Placebo group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAO supplement | Drug | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Zhang | Contact | 02552271029 | 0086 | ahzhangzhenyu@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Zhang | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhenyu Zhang | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Placebo | Drug | 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. |
|
|
| 4 weeks of study medication administration |
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 |
| D004066 | Digestive System Diseases |