The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
NCT07453823, Not applicable, Recruiting, Chr Hansen - part of Novonesis
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals | ClinicalTrials.gov |
| NCT number | NCT07453823 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chr Hansen - part of Novonesis | ClinicalTrials.gov |
| Conditions | Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms | ClinicalTrials.gov |
| Interventions | Synbiotic, Placebo | ClinicalTrials.gov |
| First posted | 2026-03-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Bifidobacterium abundance | From baseline to end of intervention at 8 weeks | Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing. | ClinicalTrials.gov |
| Secondary | Stool frequency | From baseline to end of intervention at 8 weeks | Change in number of daily bowel movements from 2 weeks average prior to baseline to 2 weeks average prior to end of intervention. An increase is desirable. | ClinicalTrials.gov |
| Secondary | Fecal acetate | From baseline to end of intervention at 8 weeks. | Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. | ClinicalTrials.gov |
| Secondary | Fecal propionate | From baseline to end of intervention at 8 weeks. | Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. | ClinicalTrials.gov |
| Secondary | Fecal butyrate | From baseline to end of intervention at 8 weeks | Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks. | ClinicalTrials.gov |
| Secondary | Zonulin | From baseline to end of intervention at 8 weeks | Change in serum zonulin from baseline to 8 weeks | ClinicalTrials.gov |
| Secondary | Lipopolysaccharide binding protein (LPS-BP) | From baseline to end of intervention at 8 weeks | Change in plasma LPS-BP from baseline to 8 weeks | ClinicalTrials.gov |
| Secondary | Interleukin 6 (IL-6) | From baseline to end of intervention at 8 weeks | Change in serum IL-6 from baseline to 8 weeks | ClinicalTrials.gov |
| Secondary | High-sensitivity C-Reactive Protein (hsCRP) | From baseline to end of intervention at 8 weeks | Change in serum hsCRP from baseline to 8 weeks. | ClinicalTrials.gov |
| Secondary | Fecal Short-Chain Fatty Acids (SCFA) | From baseline to end of intervention at 8 weeks | Change in composite measurement of fecal SCFAs panel with targeted metabolomics (GC-MSMS) from baseline to 8 weeks. Total composite is defined as: acetate + propionate + butyrate. | ClinicalTrials.gov |
| Secondary | Stool consistency | From baseline to end of intervention at 8 weeks | Change in mean stool consistency assessed daily from 2 weeks prior to baseline to daily 2 weeks prior to end-of intervention. Stool consistency will be assessed by Bristol stool chart scale rated Type 1 (separate hard lumps) to Type 7 (watery, no solid pieces). An increase in stool consistency is desirable. | ClinicalTrials.gov |
| Secondary | Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score | From baseline to end of intervention at 8 weeks | Change in GSRS-IBS composite score from baseline to end-of-intervention visit. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable. | ClinicalTrials.gov |
| Other | Recovery of probiotic strains | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up | Recovery and colonization of strains by strain specific qPCR of fecal samples | ClinicalTrials.gov |
| Other | Total relative abundance of Bifidobacterium | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up. | Change in total relative abundance of Bifidobacterium after 2 weeks of follow-up (no intervention) compared to effect after 3 weeks and 8 weeks of intervention. | ClinicalTrials.gov |
| Other | Microbiome composition and taxonomic profiles | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up | Changes in gut microbiome composition and taxonomic profiling analyzed by shotgun metagenomic sequencing of fecal samples | ClinicalTrials.gov |
| Other | Microbiome functional profiling | Basline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up | Change in gut microbiome functional profiling analyzed by shotgun metagenomic sequencing of fecal samples | ClinicalTrials.gov |
| Other | Plasma Metabolomics | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up | Change in blood metabolome as assessed by untargeted and targeted metabolomics from plasma samples | ClinicalTrials.gov |
| Other | Fecal metabolomics | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up | Change in fecal metabolome as assessed by untargeted and targeted metabolomics from fecal samples | ClinicalTrials.gov |
| Other | Bacterial HMO utilization genes | Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up | Abundance development over time of HMO degradation and modification genes such as Glycosyl hydrolases, encoded by probiotic supplements and endogenous gut species | ClinicalTrials.gov |
| Other | HMO concentration in blood and feces | Baseline, 3 weeks and end of intervention at 8 weeks | Change in HMO in plasma and fecal samples after 3 and 8 weeks of supplementation | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Symbol Coding | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)