Bowel DysfunctionPhase 1/2ANCT04507945

Stablishment of Prevention and Treatment System for Intestinal Dysfunction

A Phase 1/2 study testing Nutritional Therapy, Metabolic Disorder, Regular in people with Bowel Dysfunction, run by Nanjing University School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Dysfunction and intestinal endocrine dysfunction. This project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of CID integrated therapy. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bowel Dysfunction
What is being tested?: Nutritional Therapy, Metabolic Disorder, Regular
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 1 Oct 2020to 30 Sep 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The Patients with chronic bowel dysfunction

Who cannot join

Past severe underlying diseases of the respiratory system and cardiovascular system,
Allergy to treatment-related drugs,
Pregnancy,
Accept CID surgery.

About this study

Official title: The Goal-direct Treatment of Chronic Bowel Dysfunction

Dysfunction and intestinal endocrine dysfunction. This project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of CID integrated therapy.

Conditions: Bowel Dysfunction
Being tested: Nutritional Therapy, Metabolic Disorder, Regular
Medical subject headings: Intestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutritional Therapy, Metabolic Disorder, RegularDrug
According to the result reported by Byrne, Wilmore, etc. in 1992 ~ 1995, the use of growth hormone, glutamine, modified diet and other measures proposed intestinal rehabilitation treatment. Then, check the patient's quality of life survey, nutritional status, inflammation indicators and other changes every three months, and use metabolomics and microbiomic tools to detect changes in the patient's nutritional metabolism, intestinal microecology, etc., and adjust the patient's nutritional treatment and microecological treatment based on the results Program.

Study groups in NCT04507945
Study group	Role	What they receive
living quality	Experimental	Not described Receives: Drug: Nutritional Therapy, Metabolic Disorder, Regular
complication	Experimental	Not described Receives: Drug: Nutritional Therapy, Metabolic Disorder, Regular

What is being measured

The primary outcome is the main question the study is designed to answer.

nutrition index
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202030 Sep 2023

First posted11 Aug 2020
Study start1 Oct 2020 (estimated)
Primary completion30 Sep 2021 (estimated)
Study completion30 Sep 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bowel DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: Intestinal dysfunction is defined as the damage of intestinal substance and/or function, which leads to digestion, absorption and/or mucosal barrier function.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04507945
Sponsor's protocol ID: Intestinal dysfunction
Acronym: A
Status last verified: Aug 2020
First submitted: 8 Aug 2020
Last updated: 11 Aug 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pironi L, Corcos O, Forbes A, Holst M, Joly F, Jonkers C, Klek S, Lal S, Blaser AR, Rollins KE, Sasdelli AS, Shaffer J, Van Gossum A, Wanten G, Zanfi C, Lobo DN; ESPEN Acute and Chronic Intestinal Failure Special Interest Groups. Intestinal failure in adults: Recommendations from the ESPEN expert groups. Clin Nutr. 2018 Dec;37(6 Pt A):1798-1809. doi: 10.1016/j.clnu.2018.07.036. Epub 2018 Aug 18.
PubMed 30172658
He D, Wang S, Hu H, Yin HY. [Advances in the research of protective effect of curcumin on intestinal mucosal barrier function]. Zhonghua Shao Shang Za Zhi. 2019 Feb 20;35(2):157-160. doi: 10.3760/cma.j.issn.1009-2587.2019.02.013. Chinese.
PubMed 30798584

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bowel Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Goal-direct Treatment of Chronic Bowel Dysfunction
ClinicalTrials.gov ID: NCT04507945
Acronym / sponsor ID: A / Intestinal dysfunction
Conditions: Bowel Dysfunction
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Nanjing University School of MedicineUniversity, hospital or other
Study start: 1 Oct 2020 (estimated)
Primary completion: 30 Sep 2021 (estimated)
Study completion: 30 Sep 2023 (estimated)
First posted: 11 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Dysfunction and intestinal endocrine dysfunction. This project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of CID integrated therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Intestinal dysfunction is defined as the damage of intestinal substance and/or function, which leads to digestion, absorption and/or mucosal barrier function.

Arm	Type	Receives
living quality	Experimental	Drug: Nutritional Therapy, Metabolic Disorder, Regular
complication	Experimental	Drug: Nutritional Therapy, Metabolic Disorder, Regular

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

The Patients with chronic bowel dysfunction

Key exclusion criteria (4 listed)

Past severe underlying diseases of the respiratory system and cardiovascular system,
Allergy to treatment-related drugs,
Pregnancy,
Accept CID surgery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nutritional Therapy, Metabolic Disorder, RegularAccording to the result reported by Byrne, Wilmore, etc. in 1992 ~ 1995, the use of growth hormone, glutamine, modified diet and other measures proposed intestinal rehabilitation treatment. Then, check the patient's quality of life survey, nutritional status, inflammation indicators and other changes every three months, and use metabolomics and microbiomic tools to detect changes in the patient's nutritional metabolism, intestinal microecology, etc., and adjust the patient's nutritional treatment and microecological treatment based on the results Program.	Drug	complication, living quality

Primary outcome

nutrition index
Time frame: 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Background: PubMed 30172658Pironi L, Corcos O, Forbes A, Holst M, Joly F, Jonkers C, Klek S, Lal S, Blaser AR, Rollins KE, Sasdelli AS, Shaffer J, Van Gossum A, Wanten G, Zanfi C, Lobo DN; ESPEN Acute and Chronic Intestinal Failure Special Interest Groups. Intestinal failure in adults: Recommendations from the ESPEN expert groups. Clin Nutr. 2018 Dec;37(6 Pt A):1798-1809. doi: 10.1016/j.clnu.2018.07.036. Epub 2018 Aug 18.
Results publication: PubMed 30798584He D, Wang S, Hu H, Yin HY. [Advances in the research of protective effect of curcumin on intestinal mucosal barrier function]. Zhonghua Shao Shang Za Zhi. 2019 Feb 20;35(2):157-160. doi: 10.3760/cma.j.issn.1009-2587.2019.02.013. Chinese.
Individual participant dataSharing planned: No

Related trials for Bowel Dysfunction

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nutritional Therapy, Metabolic Disorder, Regular in people with Bowel Dysfunction, run by Nanjing University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nutrition index (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04507945, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.