Trial · NCT05776940
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
NCT05776940, Phase 3, Unknown, Air Force Military Medical University, China
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis. Trials, record NCT05776940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05776940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
- NCT number
- NCT05776940
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 116 participants, estimated
- Lead sponsor
- Air Force Military Medical University, China
- Conditions
- Immunoglobulin Light-chain Amyloidosis
- Interventions
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab, Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
- First posted
- 2023-03-20
- Last updated
- 2023-03-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of diarrhea | Up to 3 months after enrollment | Increased stool frequency and/or loose or watery stools |
| Secondary | Time before diarrhea | Up to 3 months after enrollment | Time interval from the start of treatment to the first diarrhea |
| Secondary | Duration of the diarrhea | Up to 6 months after enrollment | The time between the start of diarrhea and the last diarrhea. |
| Secondary | Hematological response at 3 and 6 months after enrollment | Up to 6 months after enrollment | Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis. |
| Secondary | Involved organ response（heart）at 3 and 6 months after enrollment | Up to 6 months after enrollment | Involved organ response（heart）is evaluated according to the change of NT-proBNP. |
| Secondary | SF-36 score at 1 month, 3 month and 6 month | Up to 6 months after enrollment | The general health condition is evaluated by the 36-item Short-Form. The SF-36 measure consists of 36 items that address the following 8 dimensions: physical pain, mental health, general health, emotional role functioning, social functioning, vitality, and physical and role functioning. Each dimension receives a final score between 0 and 100, with 100 representing the best performance. |
| Secondary | GSRS score at 1 month, 3 month and 6 month | Up to 6 months after enrollment | The Gastrointestinal Symptoms are evaluated by Gastrointestinal Symptom Rating Scale. The minimum and maximum values is 15 and 105, respectively. The scores are calculated by taking the mean of the items completed within an individual scale, with higher scores indicating greater severity of symptoms. |
| Secondary | Other adverse events that occurred during the treatment | Up to 6 months after enrollment | Adverse events are evaluated according to the CTCAE 5.0. |
| Secondary | Survival status at study endpoints | From date of randomization until the date of death from any cause, assessed up to 36 months | Survival status（live or dead） |
| Secondary | Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment | Up to 6 months after enrollment. | The changes of gut microbiome are evaluated by 16sRNA (such as Microbiota α-diversity and β-diversity、Changes in gut microbiota at the phylum and the genus levels、Phylogenetic profiles of the gut microbial communities、Microbial functional alteration、Correlations between significantly different ASVs and clinical characteristics in AL amyloidosis patients.etc.) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Data dates
The day each source was copied for this release.
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 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/NCT05776940
GET https://conductscience.org/api/trials/v1/NCT05776940/registered