Artificial Intelligence-based Dietary Care System (AI DC-system)

June 3, 2026 updated by: National Taiwan University Hospital

Effectiveness of An Artificial Intelligence-based Dietary Care System for Distress From Altered Bowel Function and Quality of Life in Rectal Cancer Patients With Low Anterior Resection Syndrome

Patients with rectal cancer complicated by low anterior resection syndrome who undergo anal-preserving surgery may experience severe distress in daily life due to changes in bowel function, thus requiring significant post-discharge care support from healthcare professionals. This study is a multicenter, non-blinded randomized controlled trial. One hundred patients with rectal cancer complicated by low anterior resection syndrome are planned to be randomly assigned in a 1:1 ratio from the colorectal surgery outpatient clinics of National Taiwan University Hospital, its Cancer Center, and its Yunlin Branch. They will be divided into a control group receiving routine dietary education and an experimental group receiving both routine dietary education and the use of an artificial intelligence-based dietary care system application. The artificial intelligence-based dietary care system application will be used for approximately six months. Three questionnaires will be administered at one month post-surgery (before intervention), three months post-surgery, and six months post-surgery. The questionnaires will include: a demographic data sheet, a low anterior resection syndrome score, distress inventory from altered bowel functioning, and the European Organization for Research and Treatment of Cancer QLQ-30 Scale, to verify the effectiveness of the artificial intelligence-based dietary care system application in improving bowel disturbance and quality of life in patients with rectal cancer complicated by low anterior resection syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10617
        • National Taiwn University, College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Clear consciousness with ability to communicate in Mandarin or Taiwanese.
  • Histopathological confirmation of rectal adenocarcinoma.
  • Undergoing radical rectal resection or such surgery combined with temporary stoma closure.

Exclusion Criteria:

  • Diagnosis of other intestinal disorders, including intestinal tumors, bloating, obstruction, ulcerative colitis, or irritable bowel syndrome.
  • Inability to access the internet.
  • Inability to use a smartphone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artificial Intelligence-based Dietary Care System
Care program will conduct by Artificial Intelligence-based Dietary Care System.
Device: Artificial Intelligence-based Dietary Care System
  1. Large language model-based communication for patient interaction, system guidance, analytic feedback, dietary recommendations, and referral information.
  2. AI-driven image analysis using regional convolutional neural networks, linked to a database of over 100,000 meals and national dietary reference standards, enabling estimation of food types, portions, and nutrient intake.
  3. Bowel movement tracking interface for recording time, frequency, and stool characteristics.
Active Comparator: Routine care
Routine dietary education during hospitalization is provided via hospital-developed electronic materials accessible through QR code scanning.
Other: Routine Care
Content covers postoperative dietary progression, nutritional supplementation, intake principles, and food avoidance. The postoperative regimen typically advances through four stages-clear liquid, low-residue semi-liquid, low-residue soft, and regular diet-with most patients resuming normal intake within one month. Guidance emphasizes high-protein, high-calorie foods, small frequent meals, and balanced nutrition, while advising avoidance of gas-producing, odorous, coarse-fiber, greasy, spicy, pickled, and dairy products.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
This 30-item instrument assesses cancer-related QoL across global health, five functional domains (physical, role, cognitive, emotional, and social), and nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulty) [22, 23]. Higher scores for functioning and global health indicate better QoL, whereas higher symptom scores denote greater symptom burden.
Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distress Inventory for Altered Bowel Functioning (DI-ABF)
Time Frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
Developed by Lu et al., the 16-item DI-ABF measures distress arising from altered bowel functioning across three domains: daily life, emotional regulation, and social functioning, with higher scores reflecting greater distress. Cut point 9.5 divided to be no bowel-related distress (0-9.5) and bowel-related distress (>9.5).
Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Low Anterior Resection Syndrome (LARS) Score
Time Frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
Developed by Emmertsen and Laurberg [21], this tool evaluates five aspects of bowel dysfunction: flatus incontinence, fecal incontinence, bowel frequency, clustering, and urgency. Scores range from 0 to 42, with higher scores indicating more severe symptoms. Severity is categorized as no LARS (0-20), minor LARS (21-29), and major LARS (30-42).
Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202603195RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For privacy protection considerations, no individual praticipant data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AI Care Device

Clinical Trials on Artificial Intelligence-based Dietary Care System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings