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Report for Clinical Trial NCT03514784

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders

This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann. Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology & Microbiology of Baylor College of Medicine.

NCT03514784 Autism Spectrum Disorder Gastrointestinal Symptoms
MeSH:Disease Autistic Disorder Autism Spectrum Disorde Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Autism Autistic behavior

3 Interventions

Name: BB-12 with LGG (Higher Dose)

Description: BB-12 with LGG - Higher Dose (10 billion CFUs)
Type: Drug
Group Labels: 1

BB-12 with LGG (Higher Dose)

Name: Placebo

Description: Maltodextrin
Type: Drug
Group Labels: 1

Placebo

Name: BB-12 with LGG (Lower Dose)

Description: BB-12 with LGG - Lower Dose (1 billion CFUs)
Type: Drug
Group Labels: 1

BB-12 with LGG (Lower Dose)


Primary Outcomes

Description: Adverse events (Safety) will be measured by case report form (survey) that are related to BB-12 with LGG (health-promoting bacteria) or placebo treatment. The symptom grade will detail the severity of adverse events.

Measure: Effects of BB-12+LGG at different doses on adverse events (safety)

Time: 84 days

Secondary Outcomes

Description: Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the Aberrant Behavior Checklist (ABC) pre and post treatment

Measure: Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)

Time: Days 1, 21, 56 and 84

Description: Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the and the Social Responsiveness Scale-2 (SRS-2) pre and post treatment.

Measure: Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors measured with the Social Responsiveness Scale-2

Time: Days 1, 21, 56 and 84

Other Outcomes

Description: GI symptoms will be measured by the GI Severity Index.

Measure: Effects of BB-12+LGG at different doses on GI symptoms as measured by GI Symptom Severity Index

Time: Days 1, 21, 56 and 84

Description: Plasma S100A9 will indicate GI and systemic levels of inflammation. S100A9 is a damage-associated molecular pattern molecule (DAMP) released by granulocytes, which is reportedly elevated 2-fold in plasma of children with ASD.

Measure: Effects of BB-12+LGG at different doses on gut inflammation (S1009A)

Time: Days 1, 56 and 84

Description: Biological change in fecal calprotectin levels. FC is a highly accurate fecal marker of inflammation.

Measure: Effects of BB-12+LGG at different doses on gut inflammation (Fecal Calprotectin)

Time: Days 1, 56 and 84

Description: Plasma zonulin, a marker for intestinal permeability ("leaky gut"), which is often associated with inflammation.

Measure: Effects of BB-12+LGG at different doses on gut inflammation (Plasma Zonulin)

Time: Days 1, 56 and 84

Description: IL-8 can be an indicator of gut inflammation; it released from the intestinal epithelial cells during inflammation.

Measure: Effects of BB-12+LGG at different doses on gut inflammation (IL-8)

Time: Days 1, 56 and 84

Description: Using 16S rDNA analysis, this will determine microbial alpha and beta diversity and distribution of the major taxa before and after probiotic treatment.

Measure: Effects of BB-12+LGG at different doses on fecal microbial community

Time: Days 1, 56 and 84

Description: This will determine levels of metabolic markers which are reported to be abnormal in autism: fecal amino acids, ammonia, short chain fatty acids (SCFA), and phenols.

Measure: Effects of BB-12+LGG at different doses on metabolites

Time: Days 1, 56 and 84

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 S1009A

GI symptoms will be measured by the GI Severity Index.. Effects of BB-12+LGG at different doses on gut inflammation (S1009A). --- S1009A ---



HPO Nodes


HPO:
HP:0000729: Autistic behavior
Genes 559
MID2 PTCHD1 SARS1 AP1S2 SYNJ1 FMN2 UBE3A CXORF56 ST3GAL5 NAA10 OTUD6B FGF12 STXBP1 KCNB1 ASH1L NDUFAF3 PAH MAPK10 SDHD CNTNAP2 PIGC HNF1B GABRD PWRN1 TRNL1 ZC3H14 SETD5 PSMD12 PRODH TUBB3 FMR1 HCFC1 PPP2CA VPS13C PDE4D CTNNB1 KCNA2 USP9X STS B3GALNT2 MAPT NDST1 VCP ANK3 HDAC8 PDE4D NAGA DCPS TCF4 C9ORF72 POLA1 NLGN3 TSPAN7 TBX1 NR2F1 SCN1B ND1 DEAF1 MED13L MAPK8IP3 SCN1A KMT2A NEUROD2 PIGG NDUFS1 COX2 GABRD CLCN4 MEF2C SIM1 GNAO1 MED12 UFD1 RARS1 RNF135 PODXL IL1RAPL1 SATB2 SMG9 CACNA1A C12ORF4 CHD8 SH2B1 SNRPN TBC1D23 IQSEC2 PGAP3 ACOX1 RSPRY1 TRNQ NDP JMJD1C MEIS2 CC2D1A DNM1 RSPRY1 IFNG TRIM8 DPYD CC2D2A ND3 SNORD116-1 AP3B2 CTCF RPL10 TBR1 IPW GABRA5 FTSJ1 FRMPD4 TMEM216 ACSL4 PARK7 NDUFS2 KDM6B WASHC4 NUS1 TRNS1 ALMS1 FGFR1 TSC1 NTRK2 CHD2 PIGL SEC24C PIGQ SDHC ALG13 SMC1A FBXO31 HERC1 SLC9A6 TRRAP THOC2 ANKRD11 HCN1 GAMT ADNP IQSEC2 CUX2 SDHB METTL23 MECP2 UPF3B TCF4 PAK3 GRIA3 WARS2 SNORD115-1 SPATA5 NDUFAF4 TBCK EP300 HIVEP2 UBTF SYP EXT2 COMT POMT1 CRADD BCKDK SZT2 NAA10 CDKL5 SCN9A ZNF41 PIGY AP2M1 CARS2 RERE STS MAN1B1 DNM1 STXBP1 CLP1 OPHN1 COX1 HCN1 DEAF1 AGTR2 MEF2C SLC6A1 YWHAG PTEN ND5 ND4 PTEN IREB2 PIGP ZNF423 MED25 DNAJC6 NSUN2 UBA5 CNKSR2 MAGEL2 DMD ELN NONO NUS1 CAMTA1 CASK USF3 EXT2 ARV1 RREB1 NDUFA11 SRY MTOR SPECC1L NDUFAF2 HCN1 KLLN MBOAT7 NDUFB9 STXBP1 DDX3X RAI1 FOXRED1 NDUFS7 TECR LMAN2L HERC2 GP1BB PSEN1 CYFIP2 AARS1 SETD2 RFC2 NDUFAF1 PCDH19 COG5 FRMPD4 PUF60 TWNK AUTS2 PLXND1 ND6 SYT1 EZR WFS1 EP300 NFIB GRN SLC25A22 ZNF81 NLGN4X RSRC1 CUX2 GABRA2 CXORF56 KCNA1 TRNF MKRN3-AS1 ACTL6B GJA8 MICOS13 NDUFA6 NAGA TRAK1 CDH15 NDUFAF4 USP7 CLTC PRDM16 ND2 SMC3 ALDH5A1 TBX1 ZFPM2 CNTNAP2 SLC35A3 ARHGEF6 TMEM106B PCDH19 FOXG1 SKI PDE4D MECP2 KCNAB2 PRKN SIN3A CHD7 IL1RAPL1 ST3GAL3 CTCF PPM1D LIMK1 SNCA ATRX LHX1 TBL2 SHANK3 SLC1A2 UCHL1 CEP290 ZBTB20 GABRB3 DYRK1A RPS23 TM4SF20 CHD2 TAF1 SCN2A MEIS2 TBR1 YY1 RERE NDUFS4 ALG11 SLC9A7 NDUFS3 SOX2 ALG13 HERC2 NEUROD2 SLC6A8 WFS1 PIGW HNRNPH2 ARNT2 HIRA DEPDC5 REV3L IQSEC2 SNX14 SH2B1 NDUFS6 SHANK3 RAD21 GABRB2 GDI1 ACADL SLC35C1 NDUFAF3 TREM2 STAG1 ATP1A3 SIM1 SCN2A CLIP2 NDUFV1 MED12 HTRA2 TRAPPC9 SEC23B GABRA1 ALDH18A1 PIGO SETD5 RAB11B NIPBL SIK1 GRIK2 ST3GAL3 PCGF2 NRXN1 TMEM126B MECP2 GFM1 AHDC1 MED23 SCN1B ASXL3 DHCR7 GJA5 CNKSR2 AUTS2 GRIA3 EHMT1 TMEM138 TMLHE TIMMDC1 TAF1 HECW2 NDUFAF5 TBC1D24 PROKR2 DHCR7 SYNGAP1 MED13L MECP2 ST3GAL5 SQSTM1 ADGRV1 SLC35A3 CLCN4 KMT5B ADSL KCNA2 ALG13 NHS EHMT1 KDM5B NDUFS8 ND1 ADNP MSTO1 AGTPBP1 SYN1 EEF1A2 TBX2 EDC3 PGAP1 TMEM237 SLC6A8 MKRN3 SON ATP6V1A CACNA1B DLG3 SCN1B PIGP AIMP1 GRIN2D LINS1 PIK3CA CHRNA7 NDN NDUFB10 DPYD UBA5 SMAD4 SLC45A1 HESX1 MCTP2 TCF20 C12ORF4 NEXMIF SNX14 EGF NALCN PRSS12 TSC2 CDKL5 AKT1 TLK2 DOCK7 CLCN4 PIGV TSC2 PPP3CA BCORL1 NLGN4X FOXP2 NDUFS4 CHD1 NDUFB11 AFF2 OTUD6B ARVCF GTF2I KCNT1 FTSJ1 RORA TRNW COX3 PIGL GABRG2 NAA15 CDKL5 PRKAR1A ARFGEF2 SYNGAP1 ARID1B BCOR PACS2 GPHN TRNH NDUFA13 KMT2C NLGN3 GNAQ TCF12 LRRK2 PPP2R5D CRBN MBOAT7 CLIP1 TBX1 PUF60 AP3B2 DHDDS PTCHD1 SLC25A12 TRNS2 USP27X HDAC4 PGAP2 WDR26 NUBPL SNRPN TRIO PWAR1 GATM STAG2 POGZ ARX PACS1 FLCN MAN1B1 MAOA NPAP1 FRRS1L GABRG2 BAZ1B HNMT WWOX POLA1 NDUFV2 GATAD2B SCN8A GABRG2 PINK1 KDM5C TUSC3 SLC13A5 SCN9A EXTL3 KPTN CACNA1C DYM ZNF711 PARS2 IQSEC1 OTX2 NEXMIF NTRK2 SOX3 SCN2A GRIN1 ARX TNIK SCN1A PNKP SLC25A1 NDUFB3 RAB39B CHD2 FOXP1 TMEM231 SCN3A RPS6KA3 STX1B FMR1 MECP2 CACNA2D2 SCN8A SEMA3E SCN1A NDUFA1 RERE CNNM2 NECAP1 GTF2IRD1 CHMP2B CREBBP TSC1 SH2B1
Protein Mutations 1
S1009A
SNP 1
rs6971