Trial · NCT07913711
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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) |
| Other | Minimal clinically important difference (MCID) in Constipation | Baseline + 8 weeks of study assessments | 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) |
| Other | Change in Reflux | Baseline + 8 weeks of study assessments | 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) |
| Other | Minimal clinically important difference (MCID) in reflux | Baseline + 8 weeks of study assessments | 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) |
| Other | Change in mental wellbeing | Baseline + 8 weeks of study assessments | 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) |
| Other | Minimal clinically important difference (MCID) in mental wellbeing | Baseline + 8 weeks of study assessments | 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) |
| Other | Change in feelings of anxiety | Baseline + 8 weeks of study assessments | 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) |
| Other | Minimal clinically important difference (MCID) in feelings of anxiety | Baseline + 8 weeks of study assessments | Likelihood of experiencing minimal clinically important difference as assessed by PROMIS Anxiety 4A (scale 4- 20; with higher scores corresponding to more severe anxiety) |
| Other | Change in mood (emotional distress-depression) | Baseline + 8 weeks of study assessments | 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) |
| Other | Minimal clinically important difference (MCID) in mood (emotional distress-depression) | Baseline + 8 weeks of study assessments | 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) |
| Other | Overall treatment effect regarding GI symptoms | Baseline + 8 weeks of study assessments | Participant-rated overall treatment effect (OTE) on GI symptoms, reported weekly during the study period |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07913711/registered