Trial · NCT07913711
Impact of Lepteridine™ Mānuka Honey in Adults With Gastrointestinal Discomfort
NCT07913711, Not applicable, Not yet recruiting, Radicle Science
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Impact of Lepteridine™ Mānuka Honey in Adults With Gastrointestinal Discomfort. Trials, record NCT07913711. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913711
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Lepteridine™ Mānuka Honey in Adults With Gastrointestinal Discomfort
- NCT number
- NCT07913711
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 775 participants, estimated
- Lead sponsor
- Radicle Science
- Conditions
- Upper Gastrointestinal Discomfort
- Interventions
- Mānuka Honey Active Product 1, Mānuka Honey Active Product 2, Placebo Control
- First posted
- 2026-11-03
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in upper GI discomfort symptoms | Baseline to Week 6 | Baseline-adjusted difference between each active treatment group and placebo at Week 6 in upper GI discomfort symptom scores, as assessed by the Nepean Dyspepsia Index (NDI) symptom checklist (scale 0-195; higher scores indicate more severe symptoms). |
| Primary | Change in upper GI discomfort related quality of life | Baseline to Week 6 | Baseline-adjusted difference between each active treatment group and placebo at Week 6 in upper GI discomfort-related quality of life, as assessed by the Nepean Dyspepsia Index (NDI) quality of life subscale (scale 0-100; higher scores indicate better quality of life). |
| Other | Minimal clinical importance difference (MCID) in upper GI discomfort symptoms | Baseline + 8 weeks of study assessments | Likelihood of achieving an MCID in upper GI discomfort symptoms, as measured by the Nepean Dyspepsia Index (NDI) symptom checklist (scale 0- 195; higher scores = more severe symptoms) |
| Other | Minimal clinical importance difference (MCID) in upper GI discomfort related quality of life | Baseline + 8 weeks of study assessments | Likelihood of achieving an MCID in upper GI discomfort related quality of life, as measured by the Nepean Dyspepsia Index (NDI) quality of life subscale (scale 0-100; higher scores = better quality of life) |
| Other | Side effect profile | 8 weeks of study assessments | Number, type, severity, causality, and outcome of side effects (adverse events/unanticipated problems) for each study arm and for the overall study |
| Other | Change in Belly Pain | Baseline + 8 weeks of study assessments | Between-group differences in outcome scores over the assessment period in belly pain score as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain) |
| Other | Minimal clinically important difference (MCID) in Belly Pain | Baseline + 8 weeks of study assessments | Likelihood of experiencing minimal clinically important difference in belly pain as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain) |
| Other | Change in Gas and Bloating | Baseline + 8 weeks of study assessments | Between-group differences in outcome scores over the assessment period in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating) |
| Other | Minimal clinically important difference (MCID) in Gas and Bloating | Baseline + 8 weeks of study assessments | Likelihood of experiencing minimal clinically important difference in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating) |
| Other | Change in Constipation | Baseline + 8 weeks of study assessments | Between-group differences in outcome scores over the assessment period in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation) |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913711
GET https://conductscience.org/api/trials/v1/NCT07913711/registered?page=2