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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK122015 | U.S. NIH Grant/Contract | View source |
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Study physician left the university
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.
The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis.
Visit 1
Day 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit.
Day 2-4 (at home):
Day 5 (Visit 2):
Day 6 (Visit 3):
Day 30-90
• Optional dietary follow-up (Day 30-90): To further assess the utility of the 24 hour dietary recall, willing participants will be invited to participate in a an optional follow-up activity during which they will complete the Automated Self-Administered Dietary Assessment Tool with or without assistance of a trained interviewer. Interested volunteers will be contacted by phone and provided instructions on how to complete the tool online by the study team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Experimental | Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. |
|
| Irritable Bowel Syndrome Patients with Diarrhea | Experimental | Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS |
|
| Irritable Bowel Syndrome Patients with Constipation | Experimental | Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin | Dietary Supplement | Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Fecal Bile Acids | Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry | 48 hours |
| Total Fecal Short Chain Fatty Acids | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | 48 hours |
| Individual Fecal Short Chain Fatty Acids - Acetate | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | 48 hours |
| Individual Fecal Short Chain Fatty Acids - Propionate | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | 48 hours |
| Individual Fecal Short Chain Fatty Acids - Butyrate | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | 48 hours |
| Fecal Microbial Population | Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Primary Fecal Bile Acids | Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectrometry. Percent primary bile acids is then calculated as primary bile acids divided by total bile acids multiplied by 100. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Energy | Optional 24-hour dietary intake will be submitted using web-based Automated Self-Administered Dietary Assessment Tool developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24/). Dietary intake within a 24-hour period in 30-90 days after study enrollment were collected. | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huiping XU | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
| FG001 | Irritable Bowel Syndrome Patients With Constipation | Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
| FG002 | Irritable Bowel Syndrome Patients With Diarrhea | Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
| BG001 | Irritable Bowel Syndrome Patients With Constipation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Fecal Bile Acids | Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry | Posted | Median | Inter-Quartile Range | mcmol/48 hours | 48 hours |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms. Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Huiping Xu | Indiana University | 317-278-6735 | huipxu@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2022 | Jul 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Fecal Inulin | Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography | 48 hours |
| Stool Characteristics - Stool Frequency in 4 Days |
Stool characteristics will be measured using a 4 day bowel diary. Stool frequency is the total number of bowel movements in 4 days summarized on the subject level. |
| 4 days |
| Stool Characteristics - Stool Form | Stool characteristics will be measured using a 4 day bowel diary. Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage,3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy,7=watery, summarized on the level of bowel movements. | 4 days |
| Stool Characteristics - Ease of Passage | Stool characteristics will be measured using a 4 day bowel diary. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements. | 4 days |
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
| BG002 | Irritable Bowel Syndrome Patients With Diarrhea | Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Irritable Bowel Syndrome Patients With Diarrhea | Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. |
|
|
|
| Primary | Total Fecal Short Chain Fatty Acids | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing data in short chain fatty acids. | Posted | Median | Inter-Quartile Range | mmol/kg | 48 hours |
|
|
|
|
| Primary | Individual Fecal Short Chain Fatty Acids - Acetate | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing data in short chain fatty acids | Posted | Median | Inter-Quartile Range | mmol/kg | 48 hours |
|
|
|
|
| Primary | Individual Fecal Short Chain Fatty Acids - Propionate | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | One subject in the group of Irritable Bowel Syndrome Patients with Constipation had missing short chain fatty acids | Posted | Median | Inter-Quartile Range | mmol/kg | 48 hours |
|
|
|
|
| Primary | Individual Fecal Short Chain Fatty Acids - Butyrate | Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry | Posted | Median | Inter-Quartile Range | mmol/kg | 48 hours |
|
|
|
|
| Primary | Fecal Microbial Population | Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is. | Microbiome sequencing was completed on all collected specimens. | Posted | Median | Inter-Quartile Range | units on a scale | 48 hours |
|
|
|
| Primary | Fecal Inulin | Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography | Measures of inulin evolved over time and many subjects did not have inulin measured as a fraction. | Posted | Median | Inter-Quartile Range | % of fructose from inulin/total fructose | 48 hours |
|
|
|
|
| Secondary | Percent Primary Fecal Bile Acids | Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectrometry. Percent primary bile acids is then calculated as primary bile acids divided by total bile acids multiplied by 100. | Posted | Median | Inter-Quartile Range | % of primary/total fecal bile acids | 48 hours |
|
|
|
|
| Secondary | Stool Characteristics - Stool Frequency in 4 Days | Stool characteristics will be measured using a 4 day bowel diary. Stool frequency is the total number of bowel movements in 4 days summarized on the subject level. | Posted | Median | Inter-Quartile Range | Number of bowel movements in 4 days | 4 days |
|
|
|
|
| Secondary | Stool Characteristics - Stool Form | Stool characteristics will be measured using a 4 day bowel diary. Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage,3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy,7=watery, summarized on the level of bowel movements. | Posted | Median | Inter-Quartile Range | score on a scale | 4 days | Bowel movements | Bowel movements |
|
|
|
|
| Secondary | Stool Characteristics - Ease of Passage | Stool characteristics will be measured using a 4 day bowel diary. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements. | Posted | Median | Inter-Quartile Range | score on a scale | 4 days | Bowel movements | Bowel movements |
|
|
|
|
| Other Pre-specified | Energy | Optional 24-hour dietary intake will be submitted using web-based Automated Self-Administered Dietary Assessment Tool developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24/). Dietary intake within a 24-hour period in 30-90 days after study enrollment were collected. | Posted | Median | Inter-Quartile Range | kcal | 24 hours |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Irritable Bowel Syndrome Patients With Constipation | Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Irritable Bowel Syndrome Patients With Diarrhea | Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS Inulin: Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D004066 | Digestive System Diseases |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |