Trial · NCT07899944
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weekly complete spontaneous bowel movements (CSBM) | Week 4 | The number of complete spontaneous bowel movements recorded in the final observation week of intervention period. |
| Secondary | Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score | Baseline, Week 4 | Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms. |
| Secondary | Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 5 | Baseline, Week 5 | Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms. |
| Secondary | Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 8 | Baseline, Week 8 | Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms. |
| Secondary | Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score | Baseline, Week 4 | Depressive symptoms assessed using the 7-item Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Total score ranges from 0 to 21; higher scores indicate more severe depressive symptoms. |
| Secondary | Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score at Week 8 | Baseline, Week 8 | Depressive symptoms assessed using the 7-item Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Total score ranges from 0 to 21; higher scores indicate more severe depressive symptoms. |
| Secondary | Change in Hospital Anxiety and Depression Scale Total score (HADS-Total) | Baseline, Week 4 | Total emotional status evaluated by the total score of Hospital Anxiety and Depression Scale, summing HADS-A and HADS-D subscale scores. Total score ranges from 0 to 42, higher scores indicate more severe emotional distress. |
| Secondary | Change in Hospital Anxiety and Depression Scale Total score (HADS-Total) at Week 8 | Baseline, Week 8 | Total emotional status evaluated by the total score of Hospital Anxiety and Depression Scale, summing HADS-A and HADS-D subscale scores. Total score ranges from 0 to 42, higher scores indicate more severe emotional distress. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) total score | Baseline, Week 4 | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) total score at Week 8 | Baseline, Week 8 | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality. |
| Secondary | Change in IBS Symptom Severity Scale (IBS-SSS) total score | Baseline, Week 4 | Overall IBS-related symptoms assessed using the IBS Symptom Severity Scale (IBS-SSS). Total score ranges from 0 to 500; higher scores indicate more severe symptoms. |
| Secondary | Change in IBS Symptom Severity Scale (IBS-SSS) total score at Week 8 | Baseline, Week 8 | Overall IBS-related symptoms assessed using the IBS Symptom Severity Scale (IBS-SSS). Total score ranges from 0 to 500; higher scores indicate more severe symptoms. |
| Secondary | Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score | Baseline, Week 4 | Quality of life assessed using the IBS-QOL. Total score ranges from 0 to 100; higher scores indicate better quality of life. |
| Secondary | Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score at Week 8 | Baseline, Week 8 | Quality of life assessed using the IBS-QOL. Total score ranges from 0 to 100; higher scores indicate better quality of life. |
| Secondary | Weekly complete spontaneous bowel movements (CSBM) at week 5 | Week 5 | The number of complete spontaneous bowel movements recorded during the first week after the end of intervention |
| Secondary | Weekly complete spontaneous bowel movements (CSBM) at week 8 | Week 8 | The number of complete spontaneous bowel movements recorded during the first week after the end of intervention. |
| Secondary | Weekly spontaneous bowel movements (SBM) | Week 5 | The number of spontaneous bowel movements recorded during the first week after the end of intervention, without the use of laxatives. |
| Secondary | Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) | Baseline, Week 4 | Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool). |
| Secondary | Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 5 | Baseline, Week 5 | Description: Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool). |
| Secondary | Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 8 | Baseline, Week 8 | Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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