An interventional study of Mānuka Honey Active Product 1 and Mānuka Honey Active Product 2 in Upper Gastrointestinal Discomfort, sponsored by Radicle Science. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
Impact of Lepteridine™ Mānuka honey in adults with gastrointestinal discomfort: a randomized, double-blind, placebo-controlled trial.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) experience pain or burning in their upper abdomen at least once a week, (2) experience mild to severe discomfort in their upper abdomen, (3) experiencing vomiting less than once per week due to GI discomfort, (4) reports no physical cause for GI symptoms, and (5) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Radicle Science is the lead sponsor of 66 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Exclusion Criteria:
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known and/or a significant safety risk with any of the study product ingredients. This may include:
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. This may include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mānuka Honey Active Product 1
Other: Mānuka Honey Active Product 1
Mānuka Honey Active Product 2
Other: Mānuka Honey Active Product 2
Placebo Control
Other: Placebo Control
Participants will use their Mānuka Honey Active Product 1 as directed for a period of 6 weeks.
Participants will use their Mānuka Honey Active Product 2 as directed for a period of 6 weeks.
Participants will use their Placebo Control as directed for a period of 6 weeks.
Change in upper GI discomfort symptoms
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).
Time frame: Baseline to Week 6
Change in upper GI discomfort related quality of life
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).
Time frame: Baseline to Week 6
Minimal clinical importance difference (MCID) in upper GI discomfort symptoms
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)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinical importance difference (MCID) in upper GI discomfort related quality of life
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)
Time frame: Baseline + 8 weeks of study assessments
Side effect profile
Number, type, severity, causality, and outcome of side effects (adverse events/unanticipated problems) for each study arm and for the overall study
Time frame: 8 weeks of study assessments
Change in Belly Pain
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)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in Belly Pain
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)
Time frame: Baseline + 8 weeks of study assessments
Change in Gas and Bloating
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)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in Gas and Bloating
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)
Time frame: Baseline + 8 weeks of study assessments
Change in Constipation
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)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in Constipation
Likelihood of experiencing minimal clinically important difference in constipation, as measured by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
Time frame: Baseline + 8 weeks of study assessments
Change in Reflux
Between-group differences in outcome scores over the assessment period in reflux score as assessed by PROMIS Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in reflux
Likelihood of experiencing minimal clinically important difference in reflux as assessed by PROMIS Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)
Time frame: Baseline + 8 weeks of study assessments
Change in mental wellbeing
Between-group differences in outcome scores over the assessment period in mental wellbeing score as assessed by World Health Organization Five Well-Being Index (scale 0- 25; where the higher scores correspond to better mental wellbeing)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in mental wellbeing
Likelihood of experiencing minimal clinically important difference in mental wellbeing, as measured by World Health Organization-Five Well-Being Index (scale 0-25; where the higher scores correspond to better mental wellbeing)
Time frame: Baseline + 8 weeks of study assessments
Change in feelings of anxiety
Between-group differences in outcome scores over the assessment period as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of experiencing minimal clinically important difference as assessed by PROMIS Anxiety 4A (scale 4- 20; with higher scores corresponding to more severe anxiety)
Time frame: Baseline + 8 weeks of study assessments
Change in mood (emotional distress-depression)
Between-group differences in outcome scores over the assessment period in emotional distress score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: Baseline + 8 weeks of study assessments
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: Baseline + 8 weeks of study assessments
Overall treatment effect regarding GI symptoms
Participant-rated overall treatment effect (OTE) on GI symptoms, reported weekly during the study period
Time frame: Baseline + 8 weeks of study assessments
Rome IV functional GI disorder profile
Baseline functional gastrointestinal disorder characteristics as assessed by the Rome IV Diagnostic Questionnaire (R4DQ); administered at baseline only, used to characterize participants
Time frame: Baseline
Change in at-home (direct-to-consumer) specimen assays
Between-group differences in changes in specimen assay results from baseline to the end of study product usage (Week 6), among participants who consented to optional biospecimen collection.
Time frame: Baseline + Week 6
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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