Trial Outcomes & Findings for Stool Transplantation for Treatment of Insulin Resistance in Morbidly Obese Patients (NCT NCT02970877)

NCT ID: NCT02970877

Last Updated: 2025-04-24

Results Overview

Looking at the change in Homeostasis model of assessment for insulin resistance (HOMA-IR). HOMA-IR \> 2.73 is considered as insulin resistance. The higher HOMA-IR, the worse the insulin resistance. For this measure, we looked at the change in HOMA-IR. Those with more reduction in HOMA-IR experience more improvement in their insulin resistance.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 month, 3 month
• Results posted on: 2025-04-24

Participant Flow

Participant milestones

Measure	Allogenic Treatment Group Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Overall Study STARTED	15	14
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	13 Participants n=13 Participants	28 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=13 Participants	0 Participants n=28 Participants
Age, Continuous	45.0 years n=15 Participants	48.0 years n=13 Participants	46.5 years n=28 Participants
Sex: Female, Male Female	12 Participants n=15 Participants	10 Participants n=13 Participants	22 Participants n=28 Participants
Sex: Female, Male Male	3 Participants n=15 Participants	3 Participants n=13 Participants	6 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	15 participants n=15 Participants	13 participants n=13 Participants	28 participants n=28 Participants
HOMA-IR	3.88 Index n=15 Participants	4.92 Index n=13 Participants	4.34 Index n=28 Participants

PRIMARY outcome

Timeframe: 1 month, 3 month

Looking at the change in Homeostasis model of assessment for insulin resistance (HOMA-IR). HOMA-IR > 2.73 is considered as insulin resistance. The higher HOMA-IR, the worse the insulin resistance. For this measure, we looked at the change in HOMA-IR. Those with more reduction in HOMA-IR experience more improvement in their insulin resistance.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Insulin Resistance Compared to Baseline Baseline to 1 mo	-0.25 Index Interval -0.76 to 2.45	1.16 Index Interval -0.49 to 3.14
Change in Insulin Resistance Compared to Baseline Baseline to 3 mo	-0.04 Index Interval -0.8 to 2.12	0.93 Index Interval -0.68 to 2.52

SECONDARY outcome

Timeframe: Baseline, 1 mo, 3 mo

Body weight (kg)

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Weight Baseline	126.8 Kg Interval 107.2 to 133.5	122.8 Kg Interval 119.0 to 138.2
Weight 1 mo	123.8 Kg Interval 107.6 to 134.0	122.0 Kg Interval 120.4 to 138.0
Weight 3 mo	125.8 Kg Interval 107.8 to 138.6	126.4 Kg Interval 120.8 to 134.0

SECONDARY outcome

Timeframe: Baseline, 1 mo, 3 mo

Weight (kg)/ height (m^2)

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Body Mass Index Baseline	43.0 kg/m^2 Interval 39.0 to 46.9	45.1 kg/m^2 Interval 40.9 to 50.8
Body Mass Index 1 mo	43.2 kg/m^2 Interval 39.15 to 47.67	44.8 kg/m^2 Interval 41.4 to 52.1
Body Mass Index 3 mo	42.64 kg/m^2 Interval 39.04 to 47.23	44.91 kg/m^2 Interval 37.95 to 54.0

SECONDARY outcome

Timeframe: Baseline, 1 mo, 3 mo

Appetite score according to visual analog scale. Scores range from 0 to 10. In hunger, zero means not hungry at all. In prospective consumption, 0 means "don't think they can eat anything at all" and lower score is better. In sweet craving, zero means "they very much would like to eat something sweet", thus, higher score is better.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Appetite Score Hunger (Baseline)	5.5 score on a scale of 1 to 10 Interval 3.1 to 6.5	5.5 score on a scale of 1 to 10 Interval 2.0 to 6.6
Appetite Score Prospective consumption (Baseline)	7.3 score on a scale of 1 to 10 Interval 4.6 to 8.8	6.1 score on a scale of 1 to 10 Interval 4.5 to 8.3
Appetite Score Prospective consumption (1 mo)	4.9 score on a scale of 1 to 10 Interval 2.3 to 5.3	3.9 score on a scale of 1 to 10 Interval 2.3 to 5.5
Appetite Score Hunger (3 mo)	3.6 score on a scale of 1 to 10 Interval 2.6 to 4.8	2.9 score on a scale of 1 to 10 Interval 2.1 to 4.2
Appetite Score Sweet craving (Baseline)	2.8 score on a scale of 1 to 10 Interval 1.5 to 5.0	1.4 score on a scale of 1 to 10 Interval 0.5 to 4.6
Appetite Score Sweet craving (3 mo)	6.8 score on a scale of 1 to 10 Interval 4.3 to 9.0	3.3 score on a scale of 1 to 10 Interval 1.6 to 5.0

SECONDARY outcome

Timeframe: Baseline, 3 mo

RAND 36-Item Health Survey 1.0 (SF-36). It is a 36-item questionnaire that asks questions about physical functioning, bodily pain, emotional well-being, social functioning, energy/fatigue, and general health perceptions, role limitations due to physical health problems, role limitations due to personal or emotional problems. The lowest score is 0 and the highest score is 100. Higher score shows better overall quality of life.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Quality of Life Questionnaire Energy/Fatigue (Baseline)	43 score on a scale Interval 35.0 to 60.0	50 score on a scale Interval 20.0 to 50.0
Quality of Life Questionnaire Energy/Fatigue (3 mo)	55 score on a scale Interval 35.0 to 65.0	45 score on a scale Interval 15.0 to 55.0
Quality of Life Questionnaire Emotional wellbeing (Baseline)	78 score on a scale Interval 48.0 to 80.0	76 score on a scale Interval 52.0 to 80.0
Quality of Life Questionnaire Emotional wellbeing (3 mo)	80 score on a scale Interval 64.0 to 88.0	72 score on a scale Interval 48.0 to 88.0

SECONDARY outcome

Timeframe: Baseline, 3 mo

Montgomery-Åsberg Depression Rating Scale (MADRS) is used in assessing severity od depressive episode. The score for each question is combined for the total score which ranges from 0 to 60. Zero means no depressive episode and 60 means severe depression.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Depression Score Baseline	5 score on a scale Interval 1.0 to 14.0	9 score on a scale Interval 4.0 to 12.0
Depression Score 3 mo	0 score on a scale Interval 0.0 to 4.0	12 score on a scale Interval 2.0 to 19.0

SECONDARY outcome

Timeframe: Baseline, 3 mo

Hamilton Anxiety Rating Scale (Ham-A) is a questionnaire that assesses anxiety. The scale is 0 to 30. 0 means no anxiety present and 30 means severe anxiety.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Anxiety Score Baseline	4 score on a scale Interval 1.0 to 13.0	7 score on a scale Interval 4.0 to 11.0
Anxiety Score 3 mo	1 score on a scale Interval 0.0 to 7.0	10 score on a scale Interval 4.0 to 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Blood measurement which measures proportion of glycated hemoglobin to total hemoglobin. This measurement assesses the blood glucose control in the last 3 months. Generally, hemoglobin A1c < 0.060 is normal, 0.060 ≤ hemoglobin A1c <0.065 is prediabetic and ≥ 0.065 is diabetic.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Hemoglobin A1c Baseline	0.05 ratio glycated Hb to total Hb Interval 0.05 to 0.06	0.05 ratio glycated Hb to total Hb Interval 0.05 to 0.06
Hemoglobin A1c 1 mo	0.06 ratio glycated Hb to total Hb Interval 0.05 to 0.06	0.06 ratio glycated Hb to total Hb Interval 0.05 to 0.06
Hemoglobin A1c 3 mo	0.06 ratio glycated Hb to total Hb Interval 0.05 to 0.06	0.06 ratio glycated Hb to total Hb Interval 0.05 to 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Measured by metagenomic sequencing. This measurement assesses the change in bacterial relative abundance level (in percentage) in the stool following the treatment. Higher values of beneficial bacteria and lower values of harmful bacteria is better. Thus, it is expected that post-FMT, beneficial bacteria will increase and harmful bacteria decrease.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Intestinal Microbiome in Stool, Composition Holdemanella biformis (Baseline to 1mo)	-0.000279 change in percentage Standard Error 0.000865	-0.000201 change in percentage Standard Error 0.00239
Change in Intestinal Microbiome in Stool, Composition Blautia obeum (Baseline to 1mo)	-0.0282 change in percentage Standard Error 0.0546	-0.00560 change in percentage Standard Error 0.545
Change in Intestinal Microbiome in Stool, Composition Clostridium spiroforme (Baseline to 1mo)	0.199 change in percentage Standard Error 0.116	-0.584 change in percentage Standard Error 0.545
Change in Intestinal Microbiome in Stool, Composition Flavonifractor plautii (Baseline to 1mo)	-0.0426 change in percentage Standard Error 0.138	-0.474 change in percentage Standard Error 0.101
Change in Intestinal Microbiome in Stool, Composition Collinsella massiliensis (Baseline to 1mo)	1.15 change in percentage Standard Error 3.49	0.284 change in percentage Standard Error 0.903
Change in Intestinal Microbiome in Stool, Composition Escherichia coli (Baseline to 1mo)	-0.00262 change in percentage Standard Error 0.0189	-0.00578 change in percentage Standard Error 0.0147
Change in Intestinal Microbiome in Stool, Composition Lactococcus lactis (Baseline to 1mo)	0.345 change in percentage Standard Error 0.962	0.224 change in percentage Standard Error 0.0491
Change in Intestinal Microbiome in Stool, Composition Bacteroides xylanisolvens (Baseline to 1mo)	0.00615 change in percentage Standard Error 0.0612	-0.00135 change in percentage Standard Error 0.0228
Change in Intestinal Microbiome in Stool, Composition Roseburia intestinalis (Baseline to 3mo)	-0.078 change in percentage Standard Error 0.720	0.0374 change in percentage Standard Error 0.183
Change in Intestinal Microbiome in Stool, Composition Roseburia hominis (Baseline to 3mo)	-0.0036 change in percentage Standard Error 0.0562	-0.011 change in percentage Standard Error 0.0601
Change in Intestinal Microbiome in Stool, Composition Eubacterium eligens (Baseline to 3mo)	-0.60 change in percentage Standard Error 0.248	0.0393 change in percentage Standard Error 0.438
Change in Intestinal Microbiome in Stool, Composition Alistipes putredinis (Baseline to 3mo)	0.0237 change in percentage Standard Error 0.352	0.0235 change in percentage Standard Error 0.212
Change in Intestinal Microbiome in Stool, Composition Ruthenibacterium lactatiformans (Baseline to 3mo)	-0.15 change in percentage Standard Error 0.309	0.235 change in percentage Standard Error 0.614
Change in Intestinal Microbiome in Stool, Composition Blautia hydrogenotrophica (Baseline to 3mo)	0.00531 change in percentage Standard Error 0.104	0.0521 change in percentage Standard Error 0.169

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Blood measurement assessing the levels of lipid parameters such as cholesterol and LDL. Higher values for LDL and cholesterol may mean the person has dyslipidemia

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Blood Lipid Profile Cholesterol (Baseline)	4.80 mmol/L Interval 4.06 to 5.54	5.64 mmol/L Interval 4.82 to 5.8
Blood Lipid Profile Cholesterol (1mo)	4.16 mmol/L Interval 4.02 to 4.97	5.47 mmol/L Interval 4.87 to 5.8
Blood Lipid Profile LDL (Baseline)	2.87 mmol/L Interval 2.38 to 3.41	3.32 mmol/L Interval 2.94 to 3.68
Blood Lipid Profile LDL (1mo)	2.62 mmol/L Interval 2.22 to 2.81	3.14 mmol/L Interval 2.9 to 3.46
Blood Lipid Profile LDL (3mo)	2.54 mmol/L Interval 2.31 to 2.94	2.97 mmol/L Interval 2.67 to 3.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Total daily energy intake from 3-day food record

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Food Intake Baseline	2002 kcal Interval 1664.0 to 2743.0	1753 kcal Interval 1307.0 to 2269.0
Change in Food Intake 1 mo	1674 kcal Interval 1475.0 to 1913.0	1787 kcal Interval 1310.0 to 2169.0
Change in Food Intake 3 mo	2012 kcal Interval 1555.0 to 2608.0	1998 kcal Interval 1648.0 to 2268.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Daily fat intake (% of energy) from 3-day food record

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Food Intake Baseline	41.6 percentage of total energy intake Interval 38.5 to 48.8	46.7 percentage of total energy intake Interval 38.2 to 49.0
Change in Food Intake 1 mo	40.8 percentage of total energy intake Interval 29.4 to 48.8	38.8 percentage of total energy intake Interval 34.5 to 42.2
Change in Food Intake 3 mo	39.2 percentage of total energy intake Interval 28.0 to 44.5	41.7 percentage of total energy intake Interval 37.4 to 47.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Daily carbohydrates intake (amount g/d, energy and % of energy) from 3-day food record

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Food Intake Baseline	39.4 percentage of total energy intake Interval 35.1 to 41.7	35.6 percentage of total energy intake Interval 32.3 to 41.8
Change in Food Intake 1 mo	39.5 percentage of total energy intake Interval 31.6 to 51.4	34.9 percentage of total energy intake Interval 28.0 to 47.6
Change in Food Intake 3 mo	45.3 percentage of total energy intake Interval 32.3 to 59.0	40.7 percentage of total energy intake Interval 33.7 to 42.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Daily protein intake (amount g/d, energy and % of energy) from 3-day food record

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Food Intake Baseline	16.9 percentage of total energy intake Interval 14.8 to 21.3	16.1 percentage of total energy intake Interval 13.8 to 21.7
Change in Food Intake 1 mo	18.6 percentage of total energy intake Interval 16.9 to 20.4	18.5 percentage of total energy intake Interval 15.7 to 22.7
Change in Food Intake 3 mo	17.7 percentage of total energy intake Interval 14.2 to 23.0	18.8 percentage of total energy intake Interval 14.0 to 21.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Daily fiber intake (g) from 3-day food record

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Change in Food Intake Baseline	21 g Interval 17.0 to 24.0	18 g Interval 10.0 to 21.0
Change in Food Intake 1 mo	19 g Interval 17.0 to 27.0	14 g Interval 11.0 to 29.0
Change in Food Intake 3 mo	18 g Interval 15.0 to 32.0	18 g Interval 13.0 to 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Activity log, self-completed

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Physical Activity Baseline	5.0 min/day Interval 3.3 to 9.9	5.0 min/day Interval 2.4 to 8.3
Physical Activity 1 mo	4.9 min/day Interval 2.9 to 8.3	4.9 min/day Interval 2.1 to 8.3
Physical Activity 3 mo	4.0 min/day Interval 1.1 to 5.9	3 min/day Interval 2.0 to 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Metabolites and molecules in the stool sample measured using nuclear magnetic resonance spectroscopy.

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Stool Metabolomics Butenylcarnitine (Baseline)	0.000128 umol/g Standard Deviation 0.0000482	0.000168 umol/g Standard Deviation 0.0000690
Stool Metabolomics Butenylcarnitine (3 mo)	0.000174 umol/g Standard Deviation 0.0000963	0.000109 umol/g Standard Deviation 0.0000359
Stool Metabolomics Indole Acetic Acid (Baseline)	0.00838 umol/g Standard Deviation 0.0106	0.0186 umol/g Standard Deviation 0.0283
Stool Metabolomics Indole Acetic Acid (3 mo)	0.0131 umol/g Standard Deviation 0.0142	0.00986 umol/g Standard Deviation 0.0134
Stool Metabolomics Phenylacetic acid (Baseline)	0.672 umol/g Standard Deviation 0.368	0.491 umol/g Standard Deviation 0.386
Stool Metabolomics Phenylacetic acid (3 mo)	0.434 umol/g Standard Deviation 0.233	0.673 umol/g Standard Deviation 0.592

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 mo, 3 mo

Nuclear magnetic resonance spectroscopy

Outcome measures

Measure	Allogenic Treatment Group n=15 Participants Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 Participants Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Serum Metabolomics Kynurenine (1 mo)	2.67 umol/L Standard Deviation 0.519	3.20 umol/L Standard Deviation 1.02
Serum Metabolomics Decenoylcarnitine (Baseline)	0.227 umol/L Standard Deviation 0.0696	0.264 umol/L Standard Deviation 0.0623
Serum Metabolomics Decenoylcarnitine (3 mo)	0.226 umol/L Standard Deviation 0.0648	0.305 umol/L Standard Deviation 0.114
Serum Metabolomics Kynurenine (Baseline)	2.56 umol/L Standard Deviation 0.688	2.51 umol/L Standard Deviation 0.468
Serum Metabolomics Isoleucine (Baseline)	63.3 umol/L Standard Deviation 13.9	61.6 umol/L Standard Deviation 8.6
Serum Metabolomics Isoleucine (3 mo)	58.8 umol/L Standard Deviation 9.3	69.8 umol/L Standard Deviation 18.2
Serum Metabolomics Leucine (Baseline	112 umol/L Standard Deviation 23.6	122 umol/L Standard Deviation 19.5
Serum Metabolomics Leucine (3 mo)	111 umol/L Standard Deviation 16	135 umol/L Standard Deviation 33

Adverse Events

Allogenic Treatment Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Autologous Control Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Allogenic Treatment Group n=15 participants at risk Fecal filtrate from 150 g stool from healthy lean donors Fecal filtrate from 150 g stool from healthy lean donors: 150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.	Autologous Control Group n=13 participants at risk Fecal filtrate from 150 g of the recipient's own stool Fecal filtrate from 150 g of the recipient's own stool: 150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
Gastrointestinal disorders Diarrhea	20.0% 3/15 • Number of events 3 • Adverse events were collected at 1month and 3months post-FMT.	30.8% 4/13 • Number of events 4 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Abdominal pain	13.3% 2/15 • Number of events 2 • Adverse events were collected at 1month and 3months post-FMT.	30.8% 4/13 • Number of events 4 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Stomach cramp	40.0% 6/15 • Number of events 6 • Adverse events were collected at 1month and 3months post-FMT.	15.4% 2/13 • Number of events 2 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Blaoting	33.3% 5/15 • Number of events 5 • Adverse events were collected at 1month and 3months post-FMT.	30.8% 4/13 • Number of events 4 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Passing more gas than usual	53.3% 8/15 • Number of events 8 • Adverse events were collected at 1month and 3months post-FMT.	38.5% 5/13 • Number of events 5 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Nausea/vomiting	26.7% 4/15 • Number of events 4 • Adverse events were collected at 1month and 3months post-FMT.	15.4% 2/13 • Number of events 2 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Foul smelling stool	0.00% 0/15 • Adverse events were collected at 1month and 3months post-FMT.	15.4% 2/13 • Number of events 2 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Abdominal distension	0.00% 0/15 • Adverse events were collected at 1month and 3months post-FMT.	15.4% 2/13 • Number of events 2 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders abdominal tenderness	0.00% 0/15 • Adverse events were collected at 1month and 3months post-FMT.	7.7% 1/13 • Number of events 1 • Adverse events were collected at 1month and 3months post-FMT.
Gastrointestinal disorders Incontinence	0.00% 0/15 • Adverse events were collected at 1month and 3months post-FMT.	7.7% 1/13 • Number of events 1 • Adverse events were collected at 1month and 3months post-FMT.
General disorders Headache	20.0% 3/15 • Number of events 3 • Adverse events were collected at 1month and 3months post-FMT.	0.00% 0/13 • Adverse events were collected at 1month and 3months post-FMT.

Additional Information

Scientific Associate

University Health Network

Phone: 416-340-5159

Email: kschweng@uhnresearch.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place